Tool Room Engineer

Manufacturing Engineer

Development Engineer (Product Quality) 

Process Engineering Manager

Site Quality Leader

HR PARTNER II

TA Supervisor

Territory Sales Executive

Head of Sales

Associate Director RA & QA

Responsibilities: People Management and Development: <ul><li>Allocate and balance work across direct reports.</li><li>Review and provide timely performance feedback to direct reports.</li><li>Mentor, develop and motivate them.</li><li>Resolve people issues in the team in order to achieve targeted department performance and enhance staffs capability and working passion.</li></ul> Toolroom Production Management <ul><li>Develop toolroom production plan.</li><li>Allocate manpower based on toolroom production plan.</li><li>Monitor toolroom production plan execution and product quality.</li><li>Monitor 5S, ISO9000, , security discipline execution.</li><li>Check and monitor production report in order to ensure toolroom production operation run smoothly and improve product quality, production efficiency, on time delivery and reduce product scrap rate.</li></ul> Continuous Improvement: <ul><li>Improve toolroom related processes.</li><li>Review staff reasonable suggestion and customer complain and push improvement action plan implementation.</li><li>Evaluate and introduce new equipment, technology and materials in order to improve toolroom production operation efficiency.</li></ul> Requirements: <ul><li>Diploma/Degree in Mechanical Engineering or equivalent.&nbsp;</li><li>3 years toolroom related work experience.</li></ul>

Responsibilities: <ul><li>Responsible for various KPI’s pertaining manufacturing engineering and Team Management skills is must.</li><li>Responsible for assembly Process, Tool Design development, (New &amp; Old tools) Qualification and Trial</li><li>Improves manufacturing efficiency by analyzing planning workflow, space requirements, and equipment layout</li><li>Work with Global COE Assembly to drive continuous improvement in Assembly Technology / Process</li><li>Maintain proper documentation and for all assembly tooling, Spares and Process Set-up&nbsp;</li><li>Ensure all Tooling / automation design drawings (Soft &amp; Hard Copy) are up to date.</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Coordinate with Manufacturing Engineer for new product development and process improvement.</li><li>Assessing resource requirements and opportunity for Automation and Process Productivity improvement</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li><li>Visit vendors for Assembly tooling assessment (Capability, Know How &amp; Capacity)</li><li>Monitoring of AM and PM and Effectiveness&nbsp;</li><li>Able to run the machine and instruct and train technicians to run the machine</li><li>CCD and PLC and Electrical Knowledge Preferably</li></ul> Requirements: <ul><li>Bachelor in Mechanical Engineering major or Electrical Engineering</li><li>10+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>CAD Knowledge Must, preferably Pro E / Creo &amp; Auto-cad, Solidworks, HMI (Human Machine interface).</li><li>DFM analysis, New automation or manual assembly / Tooling RFQ.</li><li>Assembly line Tooling &amp; Tool Debugging Knowledge.&nbsp;</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity; Accountability; Communication; Outgoing&nbsp;</li><li>Ergonomic and lean manufacturing practitioner</li><li>Advance digital acumen, MES (Manufacturing Execution System) and traceability.</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>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: Execute Hiring Strategies; <ul><li>Collaborate with Regional TA Manager, Business Leaders, HR partners, and Business teams to understand short- and long-term hiring needs.</li><li>Assist in developing and executing hiring plans, executing Global SLAs are aligned with the Business Goals</li><li>Stay informed about industry trends, market conditions, and emerging hiring practices &amp; tool</li></ul> Talent Sourcing &amp; Pipeline Development: <ul><li>Build and maintain a strong pipeline of candidates for various key roles such as NPD, NPI, PDE, MPDE and many more.</li><li>Assist the Regional TA Manager to develop and implement innovative hiring strategies using Market intelligence &amp; Talent Mapping tools.</li><li>Leverage a mix of sourcing channels: Internal/External career sites, social media Hiring such as LinkedIn, TikTok, Instagram, Facebook etc., Job Boards such as JobStreet, Monster</li><li>Familiar with hiring tools such as HireEz, ZoomInfo. Leverage employee referrals, and University hiring</li></ul> Employer Branding &amp; Candidate Engagement: <ul><li>Position the company as an employer of choice in the Engineering, Tech and manufacturing space.</li><li>Create content and campaigns targeting industry professional (e.g., webinars, blog posts, meetups, TechEvents)</li><li>Craft compelling job descriptions and recruitment materials tailored for manufacturing, Production and Engineering professionals</li></ul> Full-Cycle Recruitment: <ul><li>Deliver end-to-end recruitment: sourcing, screening, interviewing, offers &amp; compensation negotiation and onboarding</li><li>Collaborate with hiring managers to define role requirements and ideal candidate profiles.</li><li>Assist implement and monitor structured interview processes, including technical assessments</li></ul> Stakeholder Management: <ul><li>Act as the primary liaison between candidates and internal stakeholders</li><li>Provide regular hiring updates, metrics, and insights to leadership</li></ul> Data-Driven Recruiting: <ul><li>Use analytics to track sourcing effectiveness, time-to-hire, offer acceptance rates, and pipeline health.</li><li>Ensure Global Hiring Metrics, SLA and targets are aligned and achieved</li><li>Publish Daily / Weekly / Monthly / Qtrly reports on the efforts and progress</li><li>Optimize hiring funnel using recruitment metrics and KPI</li></ul> Requirements: <ul><li>Overall 8+ years of experience with Minimum of 5+ years from relevant industry</li><li>Preferably an Engineer of any discipline, but not mandatory (OR) Bachelor’s degree or higher in business administration or related field</li></ul>

Role Description: <ul><li>Seeking a technically strong and commercially driven Territory Sales Executive to support the execution of strategic account plans at a regional level across Southern Germany, Austria, and Switzerland.</li><li>This role focuses on activating distribution networks, influencing contractors, and ensuring successful deployment of solutions across enterprise customer branches.</li><li>Working closely with the Strategic Account Executive and Enterprise Account Team, you will act as the key link between headquarters strategy and on-the-ground execution across an extensive distributor and contractor network.</li></ul> Responsibilities: <ul><li>Execute the strategy defined by the Strategic Account Executive across assigned regional branches.</li><li>Develop and maintain strong relationships with local and regional distributors within the territory.</li><li>Coordinate closely with Enterprise Account Teams to ensure effective coverage of enterprise and large (Bracket I) accounts, including OEM centers.</li><li>Support and engage approximately 5 key wholesalers (HQ level) and their ~90 regional branches through training and activation initiatives.</li><li>Deliver product training and technical support across distributor branches and contractor networks.</li><li>Work directly with contractors as key influencers in the sales process, ensuring they are equipped to specify and promote solutions.</li><li>Implement channel strategies to drive revenue growth and increase market share through distribution partners.</li><li>Negotiate and manage local agreements, pricing structures, and performance metrics with distributors.</li><li>Conduct regular business reviews with partners to track performance and identify growth opportunities.</li><li>Ensure full alignment and communication between stakeholders across the value chain (HQ, branches, contractors).</li><li>Promote the full portfolio including compression, controls, and electronics as part of a 360° service offering.</li><li>Travel extensively within the assigned region.</li></ul> Requirements: <ul><li>Technical degree or apprenticeship in refrigeration engineering (mandatory: Mechatroniker für Kältetechnik or equivalent).</li><li>Minimum of 5 years’ experience in a technical sales, application engineering, or channel sales role.</li><li>Strong technical understanding of HVAC/R systems, including compressors, controls, and electronics.</li><li>Proven experience working with distributors, wholesalers, and contractor networks.</li><li>Excellent interpersonal and stakeholder management skills.</li><li>Ability to work autonomously while collaborating effectively within a matrix organization.</li><li>Native-level German language skills.</li><li>Strong proficiency in Salesforce or similar CRM systems.</li><li>High willingness to travel across Southern Germany, Austria, and Switzerland.</li></ul>

Responsibilities: <ul><li>Achievement of the direct project sales targets for the Thailand business&nbsp;</li><li>To lead and implement the yearly strategic sales business plan&nbsp;</li><li>Support existing and develop new distributors/business partners to promote and sell UPS and associated critical power systems&nbsp;</li><li>Drive weekly and monthly sales meetings ensuring all sales opportunity data accuracy&nbsp;</li><li>Develop and grow strong business relationships with electrical contracting firms including, education and training, specification influence for design and construct projects, preparation of quotes for tenders and requests&nbsp;</li><li>Responsible for the development and growth of specific end user accounts</li></ul> Requirements: <ul><li>Degree/Diploma in Engineering and/or equivalent&nbsp;</li><li>Experience in leading a team&nbsp;&nbsp;</li><li>Minimum 10 years of sales and business development experience in the power management, industrial automation or related industry</li><li>Experience in selling Uninterrupted Power supplies (UPS)</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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222 overall development Jobs found

Tool Room Engineer

Manufacturing Engineer

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

HR PARTNER II

TA Supervisor

Territory Sales Executive

Head of Sales

Associate Director RA & QA

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Skills

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222 overall development Jobs found

Tool Room Engineer

Manufacturing Engineer

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

HR PARTNER II

TA Supervisor

Territory Sales Executive

Head of Sales

Associate Director RA & QA

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

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Contact Us

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