Staff/Principal Engineer, NAND TD, RDA

Commodity Sourcing Specialist

Supply Planning & Order Management Sr Specialist

TA Specialist

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality) 

Process Engineering Manager

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

Responsibilities: <ul><li>Own the site-level RDA strategy and annual roadmap aligned to NAND TD technology nodes.</li><li>Lead analysis of experimental and production flows to detect, classify, and trend systematic and random defects.</li><li>Establish, track, and report program health metrics (baseline health, detection rates, false positives, MTTR).</li><li>Direct fast containment for defect excursions: trigger tool quarantines, define hold criteria, and lead 8D corrective actions.</li><li>Architect inspection recipes and sampling strategies; optimize sensitivity, throughput, and cost of ownership.</li><li>Partner with Process Integration, Yield, and Data Science to correlate inspection signals to device performance and yield.</li><li>Influence supplier roadmaps; evaluate, qualify, and release next gen optical/e-beam inspection capabilities.</li><li>Standardize and disseminate Best Known Methods (BKM) across global TD and manufacturing sites.</li><li>Mentor, coach, and upskill engineers; develop succession plans and technical ladders within the RDA domain.</li><li>Champion safety and continuous improvement (CIP); drive kaizen/lean initiatives that improve cycle time and learning velocity.</li></ul> Requirements: <ul><li>Bachelor’s degree with 7+ years relevant semiconductor experience, or Master’s/PhD with 5+ years.</li><li>Minimum 3+ years hands-on RDA experience in semiconductor manufacturing or equipment engineering.</li><li>Demonstrated expertise in defect inspection, process monitoring, and yield learning.</li></ul> Technical Competencies <ul><li>Realtime Defect Analysis (RDA) systems and workflows.</li><li>Optical and e-beam inspection technologies.</li><li>Statistical data analysis, correlation development, and large dataset interpretation.</li><li>Semiconductor process integration and technology development.</li><li>Root cause analysis and systematic problem solving (e.g., 8D, DMAIC).</li><li>Leadership &amp; Behavioral Competencies</li><li>Recognized technical authority with the ability to influence without direct authority.</li><li>Strong mentoring and coaching mindset with proven talent development outcomes.</li><li>Clear, concise communication skills across technical and executive audiences.</li><li>Ownership-driven, execution-focused; comfortable operating in ambiguity.</li><li>Impact &amp; Success Measures</li><li>Reduced defect-related yield loss and faster learning cycles.</li><li>On-time qualification and adoption of next-generation inspection capabilities.</li><li>Uplift in organizational RDA skill depth and succession pipeline.</li><li>Alignment of inspection strategy and capability to future NAND nodes.</li></ul>

Responsibilities: Strategic Sourcing &amp; Commodity Management: <ul><li>Develop and implement india sourcing strategies aligned with business goals, market dynamics, and global category direction.</li><li>Conduct market analysis, identify cost drivers, evaluate risks, and propose mitigation actions.</li><li>Identify, evaluate and qualify suppliers that meet company requirements in quality, service, cost, sustainability and innovation.</li></ul> Supplier Management &amp; Negotiation: <ul><li>Negotiate and manage supply agreements to ensure optimal total cost of ownership and long term value creation.</li><li>Lead supplier performance reviews and drive improvement in quality, delivery, cost and service.</li><li>Build strong, transparent and collaborative relationships with new and existing suppliers.</li></ul> Cross Functional Collaboration: <ul><li>Work closely with Manufacturing, Quality, EHS and Operations teams to ensure sourcing strategies align with technical and operational needs.</li><li>Support engineering changes, new product introductions and supply transitions.</li><li>Partner with Sustainability teams to develop and implement environmentally responsible sourcing solutions.</li></ul> Process, Governance &amp; Continuous Improvement: <ul><li>Improve sourcing processes, governance and data accuracy across the region.</li><li>Support digital tools and dashboards that enhance market intelligence, supplier insights and performance tracking.</li><li>Identify and execute continuous improvement initiatives and best practices across sourcing and procurement.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Supply Chain, Business or related field.</li><li>5–10 years of relevant sourcing or procurement experience.</li><li>Willingness to travel within the India</li></ul>

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: <ul><li>Select the desired employees and develop, implement, and monitor the programs and processes used in recruitment and selection.&nbsp;</li><li>They source, recruit, screen, interview and recommend external and/or internal candidates to staff open requisitions.&nbsp;</li><li>Utilize the services of employment agencies and/or place employment ads in appropriate sources, including the intranet, Internet, and print media.&nbsp;</li><li>Responsible for developing and implementing recruiting plans and administering talent management efforts and employee referral programs, managing the resume tracking system and ensuring consistent corporate image throughout recruiting campaigns.&nbsp;</li><li>Lead end-to-end recruitment, ensuring alignment with organizational strategy and culture.</li><li>Manage end-to-end hiring process: Source, resume screen, phone screen, schedule interviews, Offer documentation and onboarding</li></ul> Requirements: <ul><li>Minimum 6+ years of experience required for this role.</li><li>Should possess expert knowledge and innovative skills to source and attract active &amp; passive talent from different sourcing channels (job boards, social media, referrals and local outreach to identify potential candidates</li><li>Communication and Stakeholder management is key to be successful in this role as you work with global stakeholders and matrix organization</li><li>Good understanding of the engineering manufacturing industries in the local market, able to map talents, develop business intelligence for sourcing strategies and techniques</li></ul> Qualification <ul><li>Experience in handling end-to-end Talent Attraction Process [Source to Onboard]</li><li>Be able to develop Recruiting Strategies basis the skill demand and complexities</li><li>Expert knowledge and Hands-on in preparing market research, Market/Talent mapping using various tools such as Talent Neuron, Draup, LinkedIn Talent Insight</li><li>Data driven: able to analyse, slice &amp; dice data, develop insights from data and be able to make decisions to drive hiring strategies</li></ul>

Responsibilities: <ul><li>Develop and execute procurement strategies to meet production and project requirements.</li><li>Analyse and provide feedback to appropriate departments on part status / requirements for fulfilling customer demand.</li><li>Manage delivery of critical component parts and product delivery with suppliers and contract manufacturing and critical supply partners to meet customer requirements.&nbsp;</li><li>Escalation of any issues to relevant sourcing analyst.</li><li>Monitor &amp; reporting KPI targets with actions– delivery on time, confirmation of purchase orders.</li><li>Invoice processing, resolving blocked invoices &amp; amendments of purchase orders</li></ul> Requirements: <ul><li>Educational Degree, Bachelor or above, Engineering background is preferred.</li><li>Minimum 5 – 7 years of experience in indirect procurement, experience in manufacturing company is a must.</li><li>Experience in at least 2 commodities including MRO, Facility, Automation line, HR services.</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>

Responsibilities: <ul><li>Perform bank reconciliation to protect the organizations assets and verify the accuracy of cash transactions.</li><li>Reconcile and analyze balance sheet accounts, ensuring accuracy through vouching for source details and resolving discrepancies.</li><li>Generate reports and perform account analysis to resolve mis-recordings before the finalization of financial statements.</li><li>Collaborate with various partners for critical financial deliverables and maintain an audit trail of supporting documents.</li><li>Handle Fixed Asset Accounting, including asset recognition, depreciation, transfer, retirement, and write-off.</li><li>Ensure compliance with internal controls and Generally Accepted Accounting Principles (GAAP), as well as Corporate Policies and Procedures (CP&amp;P). Decisions are made through standard operating procedure.</li></ul> Requirements: <ul><li>4-5 Years of Exp.&nbsp;</li><li>BS Accountancy or Any Finance Course with Accounting Knowledge</li><li>Advanced knowledge and understanding of job specific tasks and procedures, with the ability to analysze and solve complex problems independently.</li><li>Requires advanced problem solving skills and can handle complex issues independently</li><li>Skills manifested consistently in pushing limits, voluntarily stepping in without hesitation in a situation that requires assistance or even does not have complete knowledge of the situation.&nbsp;</li><li>Performs highly complex tasks and develops innovative solutions to solve problems.&nbsp;</li><li>Works autonomously, making independent decisions and taking responsibility for outcomes</li><li>Builds and maintains relationships with key stakeholders, both internal and external, and effectively communicates complext information.&nbsp;</li><li>Significant leadership experience is observed thru effective buddy system, acting as an SME, thru project involvement and stretch assignments in handling people management in a small scale responsibility.&nbsp;</li><li>Follows business practices, process and procedures. </li><li>Expected to suggest ideas to improve ways of working, quick understanding of the business and easy to provide business solutions.&nbsp;</li><li>Can assess impact of decision to the business and process.&nbsp;</li><li>Can easily communicate across level of organization without difficulty. Can able to express clearly thoughts and opinion and does challenge the status quo.&nbsp;</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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93 corporate actions Jobs found

Staff/Principal Engineer, NAND TD, RDA

Commodity Sourcing Specialist

Supply Planning & Order Management Sr Specialist

TA Specialist

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

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Staff/Principal Engineer, NAND TD, RDA

Commodity Sourcing Specialist

Supply Planning & Order Management Sr Specialist

TA Specialist

Strategic Sourcing III – Indirect Procurement

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

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