Associate Director RA & QA

Talent Acquisition Specialist

QMS – Sr Quality & Reliability Engg

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Business Intelligence Analyst

Sr. Application Developer

Cost Accountant

Document Controller

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>

Responsibilities: <ul><li>Manage full-cycle recruitment (sourcing to onboarding).</li><li>Collaborate with hiring managers to understand hiring needs.</li><li>Source candidates through job portals, social media, and referrals</li><li>Screen, interview, and assess candidates.</li><li>Coordinate interviews and manage stakeholder communication.</li><li>Maintain recruitment data and track hiring metrics.</li><li>Ensure a strong candidate experience and employer branding.</li></ul> Requirements: <ul><li>5+ years of experience in talent acquisition/recruitment.</li><li>Strong sourcing and interviewing skills.</li><li>Familiarity with ATS and recruitment tools.</li><li>Excellent communication and stakeholder management abilities.</li><li>Ability to work in a fast-paced environment.</li></ul>

Responsibilities: Policies and Procedures: <ul><li>Localize and implement global quality policy, procedures and systems; and review QA reports within the entire factory in order to ensure the business procedures in line with QS and global standards.</li></ul> Quality System Maintenance: <ul><li>Monitor the implementation of the quality policies, including internal audit policy; monitor effectiveness of quality system,involve the quality-related best practices activities; and coordinate quality system audit from customers and third parties</li><li>in order to ensure meet business development requirement and align with global quality policies.</li></ul> Internal Quality Audit: <ul><li>Prepare internal audit plan in order to ensure meet business development requirement and align with global quality policy.</li></ul> External Audit: <ul><li>Prepare the related information according to customer or quality agencies audit needs; coordinate the entire audit process</li><li>provide action plans to external parties base on the report findings,in order to ensure meet business development requirement and align with global quality policy.</li></ul> Document Control: <ul><li>Maintain document control system in order to meet business development requirement and align with global quality policy.</li></ul> Customer Satisfactory Survey: <ul><li>Organize and review customer satisfactory survey in order to meet business development requirement and align with global quality policy.</li></ul> Quality Metrics: <ul><li>Summary and analyze plant quality metrics, support the function department to drive the performance improvement.</li></ul> Requirements: Education, Technical Qualification &amp; Experience <ul><li>College Graduate</li><li>5-8 years quality system working experience</li><li>Manufacture plant quality system experience</li><li>Project management experience</li></ul>

Responsibilities: EHS Strategy &amp; Leadership: <ul><li>Develop, implement, and maintain a comprehensive EHS management system aligned with company goals and regulatory requirements.&nbsp;</li><li>Integrate EHS strategy into broader business planning and participate in leadership meetings to influence decision-making.&nbsp;</li><li>Lead change management initiatives to build a proactive safety culture across all levels of the organization.</li></ul> Risk Management &amp; Compliance: <ul><li>Conduct and advise on risk assessments, quantify and prioritize risks, and implement effective control measures.&nbsp;</li><li>Ensure compliance with OSHA, EPA, and other relevant local, state, and federal regulations.&nbsp;</li><li>Oversee contractor and visitor safety programs, including onboarding and compliance tracking.</li></ul> Training &amp; Engagement: <ul><li>Design and deliver engaging EHS training programs tailored to various roles and risk profiles.&nbsp;</li><li>Promote employee engagement through behavior-based safety (BBS), ergonomics, and wellness initiatives.&nbsp;</li><li>Champion inclusive safety practices that consider diverse employee needs and backgrounds.</li><li>Emergency Preparedness &amp; Crisis Management: Develop and maintain emergency response plans, conduct drills, and coordinate with local emergency services.&nbsp;</li><li>Lead crisis management efforts, including communication protocols and post-incident reviews.</li></ul> Environmental Sustainability: <ul><li>Implement and monitor environmental sustainability programs, including waste reduction, energy efficiency, and water conservation.</li><li>Audits, Inspections &amp; Continuous Improvement: Conduct regular audits and inspections to identify hazards and ensure compliance.&nbsp;</li><li>Use data analytics and digital tools to track performance, identify trends, and drive continuous improvement.</li><li>Hazardous Materials &amp; Waste Management: Oversee safe handling, storage, and disposal of hazardous chemicals and waste.&nbsp;</li><li>Ensure proper documentation and training related to chemical safety and spill containment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Safety, Industrial Engineering, or related field</li><li>7+ years’ experience, including 2+ years of progressive people management experience - (equivalent experience may be considered).</li><li>Proven experience in chemical handling, technical operations, and regulatory compliance.</li><li>Strong knowledge of OSHA, EPA, ISO standards, and other applicable regulations.</li><li>Proficiency in EHS software platforms and data analytics tools. Demonstrated leadership, communication, and team-building skills.</li><li>Ability to manage projects, influence cross-functional teams, and drive cultural transformation.</li></ul>

Role Description: <ul><li>Specification Sales Engineer, Low Voltage System Assemblies What you’ll do: As a Specification Engineer, you will have the opportunity to align your skills, interests, and aspirations with a role that allows you to define your own goals.</li><li>You will be responsible for expanding and maintaining a network of specifying entities—such as engineering offices, consultants, and end-users—ensuring the company is involved early in the project lifecycle.</li><li>You will influence specifications, track project sources, and ensure internal alignment to maximise opportunity conversion and solution adoption.</li></ul> Responsibilities: <ul><li>Prospecting: Identify new specifying entities and early-stage projects through proactive research and outreach.Building Relationships with Priority Specifying Entities: Cultivate long-term relationships with consultants, engineers, and end-users to influence project direction.</li></ul> <ul><li>Planning Account Actions: Develop account-specific strategies to drive specification success and long-term engagement.</li></ul> <ul><li>Planning Calls: Prepare and schedule impactful calls with specifying entities to uncover and advance project opportunities.</li></ul> <ul><li>Conducting Discovery: Gather detailed insights into customer needs, project requirements, and decision-making processes.</li></ul> <ul><li>Planning Opportunities: Align internal resources and timelines to capitalise on identified project opportunities.</li></ul> <ul><li>Drafting Initial Concepts: Create early-stage technical and commercial proposals tailored to project specifications.</li></ul> <ul><li>Transferring Descriptive Concepts to Backend: Ensure smooth handover of project concepts to internal teams for execution and follow-up.</li></ul> <ul><li>Making Bid or No Bid Decisions: Evaluate project fit and strategic value to determine pursuit strategy.</li></ul> <ul><li>Communicating with Internal Stakeholders: Coordinate with Project Sales Engineers, back office, and project management to ensure project continuity.</li></ul> Requirements: <ul><li>Educational Background: Bachelor’s or Master’s degree in Electrical Engineering, or justifiable equivalent education.</li><li>Previous Experience: 2–5 years of experience.</li><li>Required Languages: English &amp; Turkish</li></ul>

Responsibilities: <ul><li>Maintain &amp; report KPIs related to Freight, Duty, Warehousing, and Inventory to drive stakeholder engagement &amp; action.</li><li>Act as a liaison between regional supply chain leaders, Global Logistics, and Finance to collect known headwinds, tailwinds, and cost reduction projects for inclusion in the quarterly consensus forecast</li><li>Track attainment to forecast every month, including Pareto analysis of any misses &amp; gap closure plan</li><li>Challenge existing targets &amp; identify opportunities for further improvements by partnering with the Global Logistics &amp; Global Trade Services organizations</li><li>Drive adherence &amp; standardization in the Premium Freight approval workflow, including training, specific guidelines for customer liability, and data input and reconciliation at the regional level</li><li>Identify and lead a project(s) that directly contributes to freight and/or duty cost reduction</li><li>Develop guidelines for inventory stocking strategy (Make-To-Stock / Make-To-Order), Safety Stock, Lot Sizes</li><li>Collaborate with the Master Data team to review and maintain system parameters in accordance with the latter.</li><li>Lead Slow-Moving / Obsolete inventory cadence &amp; drive actions to completion, including End-of-Life procedure</li><li>Integrate with Corporate initiatives for inventory optimization (ABC/FMR, Healthy Stock methodology)</li><li>Create innovation and digitize reports for better data presentation and action determination.</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Information Systems, or a related field. A Masters degree is preferred.</li><li>Proven experience 5+ years in master data management, data governance, or a related field, preferably in a supply chain planning environment.</li><li>Strong knowledge of supply chain planning processes, including demand planning, inventory management, and production planning.</li><li>Proficiency in utilizing master data management tools and systems (e.g., SAP MDG, Informatica MDM, etc.).</li><li>Solid understanding of data governance principles, data quality management, and data lifecycle management.</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain dashboards and reports using Power BI and or Tableau</li><li>Connect to data sources including data warehouses (for example Redshift), ERP systems, and structured datasets</li><li>Prepare and transform data using Power Query, Tableau Prep, or similar tools</li><li>Build and maintain data models and calculations within BI tools to support scalable reporting</li><li>Translate business requirements into clear and effective visualizations and reports</li><li>Analyze data to identify trends, performance gaps, and opportunities for improvement</li><li>Ensure data accuracy by validating outputs against source systems and established definitions</li><li>Support user acceptance testing and incorporate feedback into reporting solutions</li><li>Maintain and enhance existing dashboards to improve usability and performance</li><li>Document key metrics, business logic, and report structures</li><li>Collaborate with cross-functional teams including business stakeholders and technical partners</li></ul> Requirements: <ul><li>Bachelor’s degree in Industrial engineering, Information Technology, Data Analytics, or related field</li><li>3 to 5 years of experience in Business Intelligence, Data Analytics, or Reporting roles</li><li>Experience developing dashboards using Power BI or Tableau</li><li>Experience working with enterprise data sources such as ERP systems or data warehouses</li><li>Experience supporting business or operational analytics, with supply chain exposure considered an advantage</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain web applications using Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Implement and manage APIs and microservices architecture</li><li>Ensure the performance, quality, and responsiveness of applications</li><li>Identify and correct bottlenecks and fix bugs</li><li>Partner with business stakeholders and operations team to identify and manage KPIs</li><li>Evaluate the performance of processes, services, and outcomes and drive performance improvement</li><li>Independently solve complex issues, lead a team of junior and mid-level developers</li><li>Other duties as assigned</li></ul> Requirements: <ul><li>Bachelor’s degree in computer science, Information Technology, or related field. Minimum of 12-15 years offull stack development related work experience</li><li>Strong oral and written communication skills</li><li>Expert in Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Strong analytical skills with the ability to collect, organize, and analyze data</li><li>Attention to detail and accuracy is critical</li><li>Working knowledge of cloud platforms (e.g., AWS, Azure)</li><li>Adept at presenting findings in MS PowerPoint and MS Word</li></ul>

Responsibilities: Product Costing <ul><li>Calculate and maintain standard costs for products.</li><li>Determine labor rates and overhead absorption rates.</li><li>Maintain costing sheets and databases, including new product costing and pricing support.</li><li>Perform quarterly standard cost updates (cost roll).</li></ul> Cost Analysis <ul><li>Analyze and explain variances including:</li><li>Purchase price.</li><li>Material usage.</li><li>Labor and machine rates.</li><li>Efficiency and overhead.</li><li>Compare actual costs to standard costs and investigate deviations.</li><li>Identify root causes of cost fluctuations.</li><li>Analyze cost trends and evaluate cost behavior (fixed vs. variable).</li></ul> Month-End Activities <ul><li>Support month-end close with cost accounting entries.</li><li>Prepare journal entries with appropriate documentation.</li><li>Ensure accurate Cost of Goods Sold (COGS) reporting in P&amp;L.</li><li>Reconcile general ledger accounts with subledgers.</li></ul> Budgeting &amp; Forecasting Support <ul><li>Support preparation of cost budgets for operations/production.</li><li>Provide historical cost data for planning and analysis.</li><li>Calculate standard costs for budget models.</li><li>Monitor actual performance vs. budget.</li><li>Support forecasting through cost projections.</li></ul> Cost Optimization &amp; Business Partnering <ul><li>Identify cost reduction opportunities through data analysis.</li><li>Track and validate savings from cost improvement initiatives.</li><li>Partner with procurement on material cost updates.</li><li>Work closely with production on labor and overhead rates.</li><li>Provide cost insights to support operational decision-making.</li></ul> Requirements: <ul><li>Education &amp; Experience.</li><li>Bachelor’s degree in Finance, Accounting, Economics, or related field.</li><li>Professional accounting qualification is a plus.</li><li>Minimum 3+ years of experience in cost accounting (manufacturing environment preferred).</li><li>Experience in product costing and standard costing methodologies.</li><li>Exposure to SAP or similar ERP systems.</li></ul> Technical Skills <ul><li>Strong understanding of cost accounting principles and practices.</li><li>Advanced proficiency in Microsoft Excel.</li><li>Knowledge of Power BI and/or VBA is an advantage.</li><li>Familiarity with integrated systems and costing modules.</li></ul> Functional &amp; Industry Experience <ul><li>Experience working in a manufacturing or production environment.</li><li>Understanding of production processes, cost drivers, and operational workflows.</li><li>Hands-on exposure to plant-level costing and operational finance.</li></ul> Core Competencies <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy.</li><li>Structured and organized approach with the ability to manage multiple priorities.</li><li>Ability to work cross-functionally and collaborate with operations and supply chain teams.</li><li>Strong communication skills in English (written and verbal).</li></ul>

Role Description : <ul><li>This role supports project teams by controlling documentation for EPC projects—identifying, uploading and distributing engineering deliverables and maintaining electronic and hardcopy repositories with accurate indexing, revision control, metadata and access permissions.</li><li>It operates EDMS (SharePoint, ProjectWise), manages the change control lifecycle (issue/revise/approve/distribute/archive) and reviews documents for completeness and contractual/QMS compliance.</li><li>The role maintains traceability, transmittals and audit trails, prepares reports, supports technical reviews and handovers, follows up on pending reviews, and safeguards data integrity and confidentiality.</li><li>Control all documentation activities: identify, upload and distribute engineering deliverables.</li></ul> Responsibilities: <ul><li>Maintain electronic and hardcopy repositories with accurate indexing, revision control and retrieval.</li><li>Operate and administer EDMS (SharePoint, ProjectWise, etc.): uploads, metadata, permissions and folder structures.</li><li>Review drawings, specifications, change orders, submittals and vendor documents for completeness, format and contractual/QMS compliance; resolve discrepancies.</li><li>Manage the change control lifecycle: issue, revise, approve, distribute, archive and retire controlled copies.</li><li>Ensure documents are correctly dated, versioned and authorized prior to release.</li><li>Maintain traceability registers, revision histories, distribution lists, transmittals and audit trails.</li><li>Prepare transmittals, distribution notices, status updates and ad?hoc project reports.</li><li>Support technical reviews, coordination meetings and project closeout / handover documentation packs.</li><li>Proactively follow up on pending actions, approvals and overdue reviews.</li><li>Develop and maintain document procedures, metadata standards and templates; identify and implement improvements.</li><li>Provide day to day support for document access, retrieval, formatting/numbering and stakeholder queries, while maintaining access controls, data integrity and compliance with internal/ISO/contractual requirements.</li></ul> Requirements: <ul><li>Bachelor’s degree (any discipline) or equivalent.</li><li>2 to 6 years’ relevant document control experience, preferably in construction, engineering, manufacturing, oil &amp; gas or EPC project environments.</li><li>Experience supporting project QMS and contractual/client requirements is preferred.</li><li>Software Proficiency: Strong with MS Office (Word, Excel).</li><li>Experience with document management systems/EDMS such as Microsoft SharePoint, Bentley ProjectWise, DocuWare, or similar document control software. Familiarity with PDF tools and CAD/PDF handling.</li></ul>

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211 identify needs Jobs found

Associate Director RA & QA

Talent Acquisition Specialist

QMS – Sr Quality & Reliability Engg

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Business Intelligence Analyst

Sr. Application Developer

Cost Accountant

Document Controller

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Skills

Industry

Location

Jobtitle

211 identify needs Jobs found

Associate Director RA & QA

Talent Acquisition Specialist

QMS – Sr Quality & Reliability Engg

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Business Intelligence Analyst

Sr. Application Developer

Cost Accountant

Document Controller

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

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