Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality) 

Process Engineering Manager

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

Project Manager

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>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: <ul><li>Own Managerial P&amp;L planning and forecasting, delivering accurate and documented forecasts and budgets</li><li>Lead and own the India FP&amp;A calendar (cross functional view – connected with S&amp;OP and Regional timeline)</li><li>Accountable for managerial P&amp;L reporting in Campari group consolidation system.</li><li>Provide visibility on P&amp;L by SKU / brand / state / channel / customer down to GP and/or CAAP and by account.</li><li>Manage SG&amp;A in collaboration with functional leaders.</li><li>Provide clarity on business performance drivers and variations vs previous forecasts, Budget and prior years</li><li>Pilar of the S&amp;OP process, leading the Volume to value conversion and ensure consistency with commercial planning.</li><li>Provide management relevant and accurate analytics providing visibility on the R&amp;O and as such, enabling effective business decisions.</li><li>Secure integrity of the Depletions/sell out reporting by brand, by state, by channel.</li><li>Understand COGS variances in collaboration with regional supply chain finance team</li><li>Work in close collaboration with controlling team to secure DD and A&amp;P accruals accuracy, documentation and relevance at all time.</li><li>Support Revenue Optimization agenda, partnering commercial team to optimize revenue performance by customers/distributors/channel and maximize profitability.</li><li>Drive internal control &amp; operating efficiency of the promotional program and trade spend.</li><li>Support Key Account managers for trade terms negotiation, providing relevant analytics.</li><li>Develop standardized Value Chain supporting commercial team needs</li><li>Develop sound and reasonable business case for innovation/new product launch/footprint expansion</li><li>Drive ROI analysis for all key initiatives – maximization of investment, share learnings.</li><li>Continually work with functional teams to drive profitable growth and strive for continuous ongoing improvement.</li><li>Drive initiatives through increased focus on the effectiveness and profitability of sales spend and through the proactive identification of profit/growth opportunities.</li><li>Represent finance and challenge financial efficacy in key cross functional forums like Exec reviews, valuation meetings.</li><li>Develop tools to support cross functional team work and decision making and help improvement of internal processes.</li><li>Support projects led by group aiming at improving analytics and efficiencies across finance</li></ul> Requirements: <ul><li>8-10 years experience in commercial finance and FP&amp;A role. Ideally close working experience with sales and marketing/ supply chain in a commercial capacity, preferably in the liquor industry or FMCG.</li><li>Qualification – Chartered Accountant</li><li>Experience in Liquor industry preferred, FMCG essential</li><li>Advanced excel and strong power-point skills</li><li>SAP, Power BI, BPC&nbsp;</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: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities: <ul><li>Manage and supervise team’s projects’ progress</li><li>Project management– meeting project milestones, cost control/savings for projects and timely project billing.&nbsp;&nbsp;</li><li>Validate suppliers’ quotations are in accordance to site requirements</li><li>Ensure sales team provide the required info to project team for efficient project execution</li><li>Support sales team during bidding phase on project structure presentation and site surveys</li><li>Be clear on project payment milestones and carry out billing timely</li><li>Monthly billing forecasting to reporting manager</li><li>Ensure proper handover to service department with full documentation</li><li>Ensure proper handover documents are submitted to clients for their signatories</li></ul> Requirements: <ul><li>Diploma or Degree in engineering</li><li>10+ years or more in project management responsibilities in low voltage systems</li><li>Experience in managing data centers projects</li><li>Experience in dealing with Contractors, Facilities managers, end users, consultants and managers</li><li>Experience in managing 3rd party subcontractors&nbsp;</li><li>Ability to communicate English with regional counterparts</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 control risk Jobs found

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality)

Process Engineering Manager

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

Project Manager

Associate Director RA & QA

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158 control risk Jobs found

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Development Engineer (Product Quality)

Process Engineering Manager

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

Project Manager

Associate Director RA & QA

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