Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

S & OE Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

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>

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</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: Factory S&amp;OE Execution Ownership: <ul><li>Own S&amp;OE execution across 4 manufacturing sites, ensuring alignment between demand, supply, and production plans</li><li>Drive short-term execution decisions to protect customer service and delivery performance</li><li>Lead plant-level weekly S&amp;OE cadences focused on exception management and recovery actions</li><li>Ensure adherence to global S&amp;OE standards, governance, and processes&nbsp;</li></ul> Operational Excellence &amp; KPI Delivery: <ul><li>Deliver against key metrics: On-Time -Delivery, Past Due, Lead Time Accuracy, Response Time, and Inventory Health</li><li>Drive root cause analysis and corrective actions for service gaps and supply constraints</li><li>Implement continuous improvement initiatives to enhance reliability, responsiveness, and efficiency</li><li>Standardize ways of working across factories to improve consistency and execution rigor</li></ul> Customer &amp; Commercial Alignment: <ul><li>Partner closely with Customer Care and Sales teams to ensure clear prioritization and fast response to demand changes</li><li>Support escalation management with structured, data-driven solutions</li><li>Translate commercial priorities into executable supply actions at plant level</li></ul> Managing Complexity, NPI &amp; Migrations: <ul><li>Ensure operational readiness for new product introductions and product migrations</li><li>Coordinate with planning, manufacturing, and supply teams to mitigate risks during transitions</li><li>Manage demand volatility and supply constraints with agility and structured decision-making</li></ul> Financial &amp; Service Performance: <ul><li>Balance service, cost-to-serve, and inventory objectives in daily execution decisions</li><li>Support achievement of working capital and cost targets through disciplined planning and execution</li><li>Use data and analytics to optimize trade-offs between service and cost</li></ul> People Leadership &amp; Capability Building: <ul><li>Lead and develop a team of ~10 S&amp;OE planners/analysts</li><li>Coach team on problem-solving, prioritization, and decision-making</li><li>Establish clear roles, accountability, and performance expectations</li><li>Build a high-performance, accountable, and collaborative team culture</li></ul> S&amp;OE Process Adoption &amp; Maturity: <ul><li>Drive adoption of global S&amp;OE processes, tools, and KPIs</li><li>Ensure high-quality data, system discipline, and process compliance (SAP, S4 Hana, IBP Response)</li><li>Support S&amp;OE maturity roadmap deployment at factory level</li></ul> Requirements: <ul><li>Bachelor’s degree in business administration, Supply Chain Management, Logistics, Industrial Engineering or a related field.&nbsp;</li><li>An MBA or master’s degree is preferred.</li><li>10+ years of experience in supply chain planning, or operations in a multinational environment.&nbsp;</li><li>Exposure to high-growth environments, NPI, and product migrations preferred.</li><li>Minimum of 4 years of experience in people management, leading diverse teams in a global environment.</li><li>Proven experience in Sales and Operations Execution (S&amp;OE) or related roles.&nbsp;</li><li>Experience in managing operational processes related to demand planning, supply chain management, and inventory optimization.</li><li>Excellent communication and interpersonal skills to engage effectively with cross-functional teams and stakeholders.</li><li>Strong analytical skills with the ability to interpret complex data and drive actionable insights.</li><li>Highly Competent with supply chain management software (SAP Must, IBP Response is a plus) and analytics tools.</li><li>Demonstrated leadership skills with the ability to lead and inspire diverse teams across different locations.</li><li>Understand business drivers and able to balance between short- and long-term objectives.</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: Customers Management: <ul><li>Handle incoming calls and emails from assigned accounts (customers) for various sales inquiries, including information on orders, lead times, incoterms, and stock availability.</li><li>Proactively communicate with customers to ensure understanding and resolution of all order-related issues.</li></ul> Analyse Demand Forecast/ Revenue &amp; Inventory Control: <ul><li>Analyze demand forecasts for assigned accounts (customers) and review/control inventory in accordance with business unit targets.</li><li>Conduct demand planning and upload forecasts to the system, managing replenishment orders and billing for consignment customer consumption.</li><li>Generate forecast and LE reports promptly and accurately for Monthly Sales Revenue.</li><li>Review customers actual demand and forecasts to meet their requirements and conduct comprehensive analysis to avoid excess inventory or non-moving stock.</li></ul> Customer Documentation &amp; File Management: <ul><li>File all relevant sales transactions, including purchase orders, order proof lists, order acknowledgments, shipping documents, shipment reports, customer&nbsp;</li></ul> Shipment Management: <ul><li>Prepare and process shipments according to customer requests.</li><li>Collaborate with Planning/Logistics to ensure on-time delivery based on customers request dates and confirm dates for STR performance.</li><li>Oversee drop-shipment orders and ensure continuous follow-up on shipment status, particularly for critical issues.</li><li>Submit credit releases to finance for held accounts.</li><li>Coordinate with Account Managers and customers to release shipments that are on hold.</li></ul> Payment Management: <ul><li>Follow up on open disputes/invoice discrepancies with Customer, Finance &amp; Sales to ensure the best possible A/R results. If necessary, issue credit/debit notes to resolve discrepancies.</li></ul> Requirements: <ul><li>Bachelor degree in related field.</li><li>5-10 years minimum in customer service/procurement or production planning, proficient in both written and spoken English, PC literate with Microsoft Window software.</li><li>Self-initiative, perseverance, people oriented and able to travel locally and aboard for short assignment</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>

Role Description:&nbsp; <ul><li>We are hiring a Supply Chain Project Engineer to lead and manage engineering and CAPEX projects within a manufacturing environment.&nbsp;</li><li>This role involves working closely with global engineering teams and plant operations to deliver projects on time, within budget, and aligned with business goals.</li></ul> Responsibilities: <ul><li>Lead end-to-end project execution (design, installation &amp; commissioning).</li><li>Support technical proposals, cost estimation, and project planning.</li><li>Coordinate with suppliers, contractors, and cross-functional teams.</li><li>Supervise installation and construction activities on-site.</li><li>Ensure projects meet EHS, quality, and food safety standards.</li><li>Manage budget, timelines, and resource planning.</li><li>Work closely with global engineering, production, maintenance, and operations teams.</li><li>Support CAPEX planning and execution for plant initiatives.</li></ul> Requirements: <ul><li>Bachelor’s degree in engineering as Mechanical, Electrical or equivalent. MBA or Management degree is preferred.</li><li>Working with manufacturing environment is preferred. Minimum 4 years of engineering experience with minimum 3 years for project management.</li><li>Knowledge of mechanical, electrical and construction/structure are required. Also, good computer background is a must.</li><li>English communication skill is necessary in both speaking and writing.</li><li>Able to work with government officers and public organizations.</li><li>Knowledge of food industry and financial issues including CAPEX&nbsp;</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>

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339 documentation skills Jobs found

Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

S & OE Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

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339 documentation skills Jobs found

Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

S & OE Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

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

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