Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality) 

Process Engineering Manager

Site Quality Leader

QC Officer

Data & ML Architect

Client Relationship Expert

Manager, Production & CI

Associate Director RA & QA

Role Description: <ul><li>The Procurement Specialist is responsible for managing the procurement of direct and indirect materials and services to ensure uninterrupted supply to manufacturing operations while achieving cost, quality, delivery, and working capital objectives. </li><li>The role partners closely with Production Planning, Operations, Quality, Finance, and Global Procurement to execute sourcing strategies, manage supplier performance, and support continuous improvement initiatives across the supply chain.&nbsp;</li><li>The successful candidate will have strong procurement execution skills, supplier management experience, and a proactive approach to resolving supply risks and driving operational excellence.&nbsp;</li></ul> Responsibilities: Procurement &amp; Supply Management&nbsp; <ul><li>Execute procurement activities for assigned direct materials, packaging materials, indirect spend categories, and services.</li><li>Convert purchase requisitions into purchase orders and manage end-to-end procurement transactions within SAP.</li><li>Ensure material availability to support production plans and customer commitments.</li><li>Monitor supplier delivery performance and proactively manage supply risks.</li><li>Coordinate with planning and operations teams to address shortages, delays, and capacity constraints.</li><li>Maintain optimal inventory levels in line with working capital and service objectives.&nbsp;</li></ul> Supplier Management&nbsp; <ul><li>Manage day-to-day supplier relationships and performance.</li><li>Monitor supplier KPIs including:&nbsp;&nbsp;On-Time Delivery (OTD), Quality performance, Lead time adherence, Responsiveness&nbsp;, Cost competitiveness</li><li>Conduct supplier performance reviews and support corrective action implementation where required.&nbsp;</li><li>Escalate supply risks and develop mitigation plans to ensure business continuity.</li></ul> Cost &amp; Contract Management <ul><li>Support sourcing initiatives and cost reduction projects.</li><li>Obtain quotations and conduct commercial evaluations.</li><li>Participate in supplier negotiations under guidance from Global Procurement or Supply Chain leadership.</li><li>Support implementation of payment term optimization initiatives.</li><li>Ensure contract pricing and procurement terms are accurately maintained within systems.&nbsp;&nbsp;</li></ul> Inventory &amp; Working Capital Management&nbsp; <ul><li>Collaborate with planning teams to optimize inventory levels.</li><li>Identify excess, obsolete, and slow-moving inventory risks.</li><li>Support inventory reduction initiatives without compromising customer service.</li><li>Monitor supplier lead times and MOQ impacts on inventory performance.</li></ul> SAP &amp; Process Excellence&nbsp; <ul><li>Maintain accurate procurement master data including:&nbsp;&nbsp;Vendor records, Pricing information, Lead times, Procurement parameters&nbsp;</li><li>Support SAP implementation and continuous process standardization initiatives.</li><li>Ensure compliance with procurement policies, approval authorities, and audit requirements.</li><li>Drive continuous improvement opportunities in procurement processes and supplier collaboration.</li></ul> Requirements:&nbsp; <ul><li>Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline.</li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred.</li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.</li><li>Experience in procurement or supply chain within a manufacturing environment.</li><li>Good understanding of supplier management, inventory control, and material planning (MRP).</li><li>Proficiency in SAP and Microsoft Excel for procurement and data analysis.</li><li>Strong communication, negotiation, and problem-solving skills.</li><li>Ability to collaborate effectively with cross-functional teams and suppliers.</li><li>Experience supporting cost-saving, process improvement, or SAP implementation initiatives.&nbsp;&nbsp;</li></ul>&nbsp;&nbsp;

Responsibilities: Order Management &amp; Fulfilment Execution <ul><li>Manage end-to-end order intake to fulfilment process ensuring alignment with customer requirements and supply capabilities.</li><li>Monitor and manage order backlog, ensuring timely resolution of constraints and prioritization.</li><li>Coordinate closely with Customer Support / Commercial teams on demand fulfilment and order commitments.</li><li>Drive proactive communication on order status, delays, and recovery plans.</li></ul> Supply Planning &amp; Prioritization <ul><li>Collaborate with Production Planners to translate demand into executable production and fulfilment plans.</li><li>Lead order prioritization decisions based on customer criticality, contractual commitments, and business impact.</li><li>Ensure optimal allocation of constrained supply across customers and regions.</li><li>Support escalation management for supply-demand imbalances.</li></ul> Capacity Planning &amp; RCCP <ul><li>Develop and maintain Rough-Cut Capacity Planning (RCCP) to ensure alignment between demand and production capacity.</li><li>Identify capacity constraints early and drive mitigation actions (e.g., alternate sourcing, schedule optimization, subcontracting).</li><li>Partner with manufacturing and procurement teams to balance load vs. capacity.</li></ul> Customer Stock Build &amp; Inventory Coordination <ul><li>Manage customer-specific stock build strategies to support service level targets and campaign demand.</li><li>Coordinate with inventory and warehouse teams to ensure optimal stock positioning Monitor and control inventory risks (excess, slow-moving, or shortages) linked to customer demand patterns.</li></ul> Cross-Functional Coordination (Control Tower Role) Act as the central coordination point between: <ul><li>Commercial / Demand Planning.</li><li>Customer Service o Production Planning.</li><li>Procurement / Logistics o Global Supply Chain team.</li><li>Drive alignment on order fulfilment strategies and execution plans.</li><li>Lead regular order fulfilment reviews and backlog governance meetings.</li><li>Performance Monitoring &amp; Continuous Improvement.</li></ul> Track and report key KPIs: <ul><li>OTIF (On-Time In-Full).</li><li>Backlog aging.</li><li>Service level adherence.</li><li>Capacity utilization.</li></ul> Identify root causes of service failures and drive corrective actions Lead or support initiatives to improve: <ul><li>Order cycle time.</li><li>Planning accuracy.</li><li>Supply chain responsiveness.</li></ul> Requirements: <ul><li>﻿Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline. </li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred. </li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.&nbsp;</li></ul>

Responsibilities: Customer Quality &amp; Technical Ownership: <ul><li>Act as the primary technical experts working closely with GQM, KQM, FSE, and internal stakeholders.</li><li>Lead customer complaint investigations, including root cause analysis using structured methodologies (e.g. 5 Whys, Fishbone, 8D), and ensure effective corrective and preventive actions (CAPA).</li><li>Ensure high-quality failure analysis (FA) reports supported by strong technical justification; challenge and close invalid or non-reproducible cases with data-driven rationale.</li><li>Drive fast response, structured escalation, and effective containment actions to improve response time and customer confidence.</li><li>Clearly translate customer complaints into technical, reliability, and risk-based problem statements.</li><li>Review customer quality documentation, including FAI, First Lot Approval, control plans, and inspection reports.</li><li>Ensure out-of-control situations are managed effectively through well-defined OCAPs, including timely containment and recovery actions.</li><li>Maintain high standards for 8D reports and monitor closure turnaround time to meet customer expectations.</li><li>Support regular customer quality reviews and maintain strong working relationships with key customer contacts.</li><li>Initiate internal technical quality improvement initiatives based on customer feedback, field failure data, and risk analysis.</li><li>Strengthen decision-making by identifying the most pragmatic solutions through cross-functional analysis of design, process, and supplier factors.</li></ul> Engineering &amp; Product Quality Assurance: <ul><li>Maintain strong product knowledge covering design intent, materials, machining, assembly, and related manufacturing processes.</li><li>Act as technical authority during escalations, challenging design or process decisions based on field data, reliability risk, and customer impact.</li><li>Support failure analysis and laboratory activities; convert findings into concrete design, process, or control improvements.</li><li>Serve as the link between field failures and design robustness, ensuring lessons learned are embedded into future products and updates.</li></ul> New Product Introduction &amp; Change Management: <ul><li>Participate in NPI and engineering change control processes to ensure customer quality, CTQ, and Copy Exact compliance.</li><li>Ensure customized or newly developed products fully meet customer specifications, quality standards, and regulatory requirements.</li><li>Provide engineering inputs for design reviews, DFMEA/DFMA, and quality guidelines from a customer and field reliability perspective.</li></ul> Culture &amp; Way of Working: <ul><li>Embody and promote company values: Integrity, Teamwork, Customer Centricity, and Innovation.</li><li>Foster a preventive mindset and risk-based thinking across engineering and quality activities.</li><li>Engage cross-functional teams with a clear focus on long-term product excellence and customer success.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical, Mechatronics, Manufacturing Engineering, or related field.</li><li>5–10+ years’ experience in customer quality, product engineering, or industrialization within high-mix, precision manufacturing (semiconductor equipment preferred).</li><li>Strong ability to read and interpret drawings, GD&amp;T, simulations, specifications, and tolerance concepts.</li><li>Hands-on experience with 8D, 5 Whys, Ishikawa, DFMEA/PFMEA, DFMA, SPC, MSA, DOE.</li><li>Strong analytical, system-level, and reliability-focused thinking.</li><li>Ability to challenge technical decisions fact-based and constructively.</li><li>Strong communication skills in English, including customer-facing and executive-level discussions.</li><li>Strong command of English for global-level communication. Proficiency in Mandarin Chinese (for Chinese customer interaction) and Malay (for shop-floor communication) is highly advantageous.</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</li></ul>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</li></ul>

Responsibilities: Strategic Leadership: <ul><li>Set the vision and direction for data and AI architecture for project and client.</li><li>Influence enterprise data and AI strategies, driving adoption of best practices in data, ML, and AI architecture.</li><li>Mentor and develop junior architects and engineers, fostering a culture of technical excellence and innovation.</li></ul> Architectural Excellence: <ul><li>Architect and design enterprise-scale data platforms and ML/AI solutions for scalability, reliability, and performance.</li><li>Define and enforce data and ML architecture standards, patterns, and governance frameworks for data pipelines, ML workflows, and analytics platforms.</li><li>Lead solution design for integrating data from diverse sources (streaming, batch, cloud, on-premises) using Azure, AWS, and GCP services.</li></ul> AI &amp; ML Leadership: <ul><li>Architect advanced Data Science, ML and AI solutions, including NLP, RAG LLM and Agentic AI systems.</li><li>Oversee the implementation of MLOps frameworks, ensuring robust deployment, monitoring, and lifecycle management of ML models.</li><li>Evaluate and recommend emerging AI/ML technologies and platforms, driving innovation in intelligent data products.</li><li>Provide Ethical AI leadership to ensure intelligent solutions are implemented when required and in safe methods.</li></ul> Technical Leadership: <ul><li>Oversee data modelling (e.g. medallion architecture), data governance, and quality frameworks. Implementing technical reviews and driving high standards.</li><li>Collaborate with engineering and DevOps teams to establish CI/CD and MLOps architectures using Azure DevOps, Kubernetes, and Terraform.</li><li>Guide the selection and implementation of visualization and analytics tools (Power BI, Tableau, PowerApps).</li></ul> Stakeholder Engagement: <ul><li>Engage with senior stakeholders to translate complex business requirements into technical solutions and strategic roadmaps.</li><li>Ensure all solutions meet security, compliance, and performance standards, and align with enterprise architecture principles.</li></ul> Innovation &amp; Emerging Technologies: <ul><li>Apply modern data and AI architecture patterns (Cloud Native, Steaming/batch ingestion, Agentic AI Design) and leverage platforms such as AI/ML, Big Data, and Data Lakehouse.</li></ul> Requirements: <ul><li>Minimum 8 years’ experience client facing roles specializing in Data and Architecture roles.</li><li>Experience in both Agile and Waterfall project environments.</li><li>Strong stakeholder management and communication skills.</li><li>Security and compliance awareness.</li><li>Industry certifications (e.g., AWS Solution Architect, Azure Data Engineer, GCP Data Engineer).</li><li>Experience mentoring or managing technical teams.</li></ul>

Responsibilities: <ul><li>Client Relationship Management: Build and maintain strong, long-term relationships with high-value clients to foster loyalty, retention, and portfolio growth opportunities.</li><li>Strategic Insight &amp; Collaboration: Analyze client trends and market insights to identify strategic opportunities, collaborating closely with team managers and cross-functional stakeholders.</li><li>Sales &amp; KPI Performance: Drive sales performance and achieve KPI targets through advanced clienteling techniques aligned with business objectives.</li><li>Product Expertise &amp; Storytelling: Demonstrate expert knowledge of products and collections, using compelling storytelling to enhance client engagement and strengthen brand identity.</li><li>Operational Excellence: Ensure operational excellence by adhering to company guidelines, maintaining compliance standards, and effectively utilizing internal tools to optimize processes and elevate the client experience.</li></ul> Requirements: <ul><li>Years of exp: 5+ years of HNI luxury retail experience would be required</li><li>Excellent verbal and written communication</li><li>Client handling and conflict resolution skills</li></ul>

Responsibilities:&nbsp; <ul><li>Train and develop team members to foster a culture of continuous improvement and operational excellence.</li><li>Be accountable of site production teams’ engagement.</li><li>Follow up site production team capabilities and create a multi functional environment.</li><li>Lead and coordinate daily production activities to meet production targets, quality standards, and delivery deadlines.</li><li>Develop and implement process improvements using continuous improvement methodologies.</li><li>Analyze production data to identify areas for efficiency gains and waste reduction.</li><li>Collaborate with cross-functional teams (engineering, quality, supply chain) to resolve production issues.</li><li>Monitor key performance indicators (KPIs) related to production efficiency, waste, safety, and quality.</li><li>Ensure compliance with safety regulations and promote a safe working environment.</li><li>Manage resources effectively, including workforce planning and equipment utilization.</li><li>Prepare reports on production.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering</li><li>Minimum 10 years of experience in production management, continuous improvement, or operational efficiency roles.</li><li>Strong expertise in Lean Manufacturing, TPM, WCM, IWS or other process improvement methodologies</li><li>Excellent analytical and problem-solving skills, with proficiency in data-driven decision-making.</li><li>Experience in the tobacco or FMCG industry is highly desirable.</li><li>Strong leadership abilities to drive change and influence teams across different levels of the organization.</li><li>Ability to manage multiple projects efficiently in a fast-paced environment.</li><li>Additional support activities as assigned.</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

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158 international standards Jobs found

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

QC Officer

Data & ML Architect

Client Relationship Expert

Manager, Production & CI

Associate Director RA & QA

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158 international standards Jobs found

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

QC Officer

Data & ML Architect

Client Relationship Expert

Manager, Production & CI

Associate Director RA & QA

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.