Associate Director RA & QA

DEA Manager

HR Systems and Workforce Analyst

Sr. Application Developer

Document Controller

Manager II – Manufacturing & Process Development Engineering

Manager, Data Engineering

On & Off Trade Specialist

Chemist Data Reviewer

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>

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>

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 : <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>

Responsibilities: Lead a team of engineers who will: <ul><li>Develop power connector assembly manufacturing process in accordance with LEANPD product development.</li><li>Drive for excellence in existing manufacturing technologies and methods.</li><li>Strive to implement new manufacturing technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for manufacturability; realizes sample tooling, product samples, and prototypes.</li><li>Design, develop, and qualify tooling and processes to meet company DDN quality and production standards.</li><li>Support the supply chain to verify supplier compliance and capability.</li><li>Act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with the project management team to understand current and future strategic business needs</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need</li><li>Provide readouts to Senior manager and Director-level cross-functional management as necessary</li><li>Work with the Philippines operations team to assign resources necessary for the successful execution of new product development</li><li>Facilitate and coordinate cross-functional communication across globally matrixed organizations</li></ul> Requirements: <ul><li>Bachelors or above degree with mechanical/electrical related majors.</li><li>At least 5 years of managerial-level experience related to a multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in the connector assembly industry is preferred.</li><li>Fluent in English and good presentation skills.</li><li>Familiar with MS software.</li><li>Familiar with industrial specification (i.e., IPC 620).</li><li>Familiar with Stamping / Plating / Molding / Assembly processes</li></ul>

Responsibilities: <ul><li>DATA &amp; ANALYTICAL SOLUTIONS: Oversees the development of data products and solutions using big data and cloud based technologies, ensuring they are designed and built to be scalable, sustainable and robust.</li><li>DATA PIPELINES: Develops and monitors streaming and batch data pipelines that facilitate the seamless ingestion of data from various data sources, transform the data into information and move to data stores like data lake, data warehouse and others.</li><li>DATA SYSTEMS: Reviews existing data systems and architectures to lead identification of areas for improvement and optimization.</li><li>DATA INFRASTRUCTURE: Oversees the preparation of data infrastructure to drive the efficient storage and retrieval of data.</li><li>DATA FORMATS: Reviews and resolves appropriate data formats to improve data usability and accessibility across the organization.</li><li>STAKEHOLDER MANAGEMENT: Partners collaboratively with multi-functional data and advanced analytic teams to capture requirements and ensure that data solutions meet the functional and non-functional needs of various partners.</li><li>DATA FRAMEWORKS: Builds complex prototypes to test new concepts and provides guidance to implement data engineering frameworks and architectures that improve data processing capabilities and support advanced analytics initiatives.</li><li>AUTOMATED DEPLOYMENT PIPELINES: Oversees the development of automated deployment pipelines improving efficiency of code deployments with fit for purpose governance.</li><li>DATA MODELING: Guides the team to perform data modeling in accordance to the datastore technology to ensure sustainable performance and accessibility.</li><li>TEAM MANAGEMENT: Manages team members to achieve the organizations goals, by ensuring productivity, communicating performance expectations, creating goal alignment, giving and seeking feedback, providing coaching, measuring progress and holding people accountable, supporting employee development, recognizing achievement and lessons learned, and developing enabling conditions for talent to thrive in an inclusive team culture.</li></ul> Requirements: <ul><li>Some experience in React, including hooks, context API, and state management libraries (Redux, Zustand)</li><li>Solid experience with JavaScript (ES6+), TypeScript, HTML5, CSS3.</li><li>Strong experience with C# and .NET Framework/.NET Core.</li><li>Solid understanding of object-oriented programming.</li><li>Experience with unit testing and mocking frameworks (e.g., xUnit, NUnit, Moq).</li><li>Familiarity with design patterns (e.g., Repository, Factory, Strategy).</li><li>Experience with SQL DBs, MySQL, Postgres, or MS SQL: writing queries, stored procedures, and performancetuning.</li><li>Knowledge of RESTful APIs and message-based systems.</li><li>Experience with relational databases and data access libraries (e.g., Entity Framework, Dapper).</li><li>Knowledge of ReactJS</li><li>Proficient in Git: branching, merging, pull requests, and version control workflows.</li></ul>

Responsibilities: <ul><li>Oversee distributor relationships, shipment delivery, depletion tracking, and overall operations</li><li>Manage all aspects of On and Off Trade execution</li><li>Ensure timely processing of purchase orders, A&amp;P budgets, and claim settlements for operational excellence</li><li>Ensuring brand availability, menu listing, and appropriate pricing in on premise outlets</li><li>Monitor outlet level inventory and plan stock replenishment aligned with sales opportunities</li><li>Ensure products are correctly priced, ticketed, and displayed across unpaid shelves and paid elements (wall bays, gondolas, shelf in shelf)</li><li>Execute in store visibility initiatives and build impactful displays as per annual plans</li><li>Manage visibility and activation calendars, ensuring flawless execution of brand experiences</li><li>Plan, execute, and review gift pack promotions to deliver pre aligned objectives</li><li>Deliver merchandising services tailored to diverse customer needs</li><li>Build and maintain strong relationships with counter salesmen, bar managers, restaurant managers, and general managers</li><li>Handle ad hoc administrative tasks as required</li></ul> Requirements: <ul><li>Self-motivator</li><li>Liquor Industry experience of 3+yrs</li><li>Ability to network and build relationships</li><li>Previous merchandising &amp;/or retail experience</li><li>Knowledge of retail activation planning/ management/ operation</li><li>High attention to detail</li><li>Excellent time management skills</li><li>Basic to intermediate MS Office (word, Excel, Outlook and PowerPoint)</li><li>Ability to work varied hours</li><li>Knowledge of the Liquor industry and regulatory environment, and communication guidelines</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

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48 ms licensing Jobs found

Associate Director RA & QA

DEA Manager

HR Systems and Workforce Analyst

Sr. Application Developer

Document Controller

Manager II – Manufacturing & Process Development Engineering

Manager, Data Engineering

On & Off Trade Specialist

On & Off Trade Specialist

Chemist Data Reviewer

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48 ms licensing Jobs found

Associate Director RA & QA

DEA Manager

HR Systems and Workforce Analyst

Sr. Application Developer

Document Controller

Manager II – Manufacturing & Process Development Engineering

Manager, Data Engineering

On & Off Trade Specialist

On & Off Trade Specialist

Chemist Data Reviewer

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