Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Business Intelligence Analyst

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: 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>

Overview: <ul><li>The HR Technology and Integration (T&amp;I) organization was established as part of the HR team’s journey through digital transformation.&nbsp;</li><li>Working as part of our Global HR Technology &amp; Integration team this role to Build, implement and improves global HR systems, data, reporting and analytics platform.&nbsp;</li><li>As a product owner you will Develop and improve existing HR systems in partnership with our Global Talent Rewards &amp; HR Services teams to meet business requirements.</li></ul> Responsibilities: <ul><li>Act as a Global Product Owner to support our Global Total Rewards systems &amp; development.</li><li>Partner closely with our Global Total Rewards team to provide product knowledge &amp; solutions.</li><li>Proactively recommend solutions and ideas to help address technical problems that hinder productivity within Total Rewards.</li><li>Collaborates with Total rewards business teams to analyse requirements, develops and implements various solutions &amp; procedures.</li><li>Provides expertise in the analysis, design, development, and implementation of our Global HRIS system &amp; applications.</li><li>Streamline &amp; continuously improve system configuration to support Global Total Rewards team</li><li>Research solutions to support HR programs and processes.</li><li>Acts as a liaison with IT (Internal &amp; External) on technical issues and projects requiring data integration and other technical support.</li><li>Troubleshoots production issues, including problem research and analysis, and performing steps for resolution.</li><li>Documents system specifications, configurations, processes and procedures.</li><li>Partners with IT, HR and business to ensure effective use of methodologies and communication of test strategies, test results and performance through testing teams</li><li>Audits and reviews changes within HRIS to ensure proper controls and separation of duties and assists in establishing new controls, as needed.</li><li>Contributes to training program development and provides Tier 3 end-user support. Partners with COE’s &amp; Shared Services on enhancements, new rollouts, etc.</li><li>Works with external vendors and other service providers to ensure the efficient, accurate, and timely exchange of information</li></ul> Requirements: <ul><li>Bachelor degree (or equivalent); advanced degree preferred.</li><li>Typically requires minimum of 5+ years of SuccessFactors experience with end to end implementation projects</li><li>SuccessFactors certification with experience and expertise in modules like Compensation and Variable Pay</li><li>Hands on experience with SuccessFactors Employee Central (EC)</li><li>Candidate should ideally have been experience in at least 1 previous global / regional implementation • Provided recommendations with half-yearly and periodic system updates</li><li>Ability to communicate recommendations and solutions to non-technical clients and end users.</li><li>Experience building and executing test scripts for HR information system upgrades and enhancements. • Desired ITIL Service Management Certified</li><li>Advanced proficiency in MS Office, especially Excel</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>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>

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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258 technical guidance Jobs found

Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Business Intelligence Analyst

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

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258 technical guidance Jobs found

Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Business Intelligence Analyst

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.

EMPLOYER

TALENT

COMPANY

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