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Executive, Regulatory Affairs – New Product Registrations
Apotex Inc.. Prepare new regulatory submissions and deficiency responses for US and Canadian regulatory agencies covering sterile injectable dosage forms .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a focus on sterile injectable dosage forms, ensuring compliance with US and Canadian regulatory requirements. Proficient in project management and collaboration across functional teams to facilitate timely regulatory submissions and responses.
Highest-signal resume keywords
Regulatory Affairs ExperienceSterile Injectable Dossier CompilationProject Management PrinciplesCross-Functional Team CoordinationRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submissions PreparationDeficiency Response CompilationQuality Document ReviewChange-Control Document AssessmentRegulatory Database MaintenanceGeneric Product Development KnowledgeTechnical Compliance UnderstandingSubmission Spreadsheet ManagementSOP DraftingRegulatory Guidelines Interpretation
Soft Skills
Excellent Communication SkillsInterpersonal SkillsPresentation SkillsInfluencing SkillsCollaborative Problem-Solving
Tools & Technologies
MS OfficeMS WordMS ExcelMS ProjectRegulatory Tracking Systems
Certifications & Qualifications
Project Management Qualification
Industry Keywords
Regulatory AffairsSterile InjectablesQuality ComplianceGlobal Regulatory RequirementsHealth SciencesPharmacyChemistryBiologyDeficiency Response ChecklistsSubmission Information Issues
About the role
Key responsibilities & impact- Prepare new regulatory submissions and deficiency responses for US and Canadian regulatory agencies covering sterile injectable dosage forms
- Review quality documents required for new product development submissions and deficiency responses
- Maintain documentation and database records for approved products according to systems, processes, and procedures
- Lead and coordinate regulatory affairs projects as assigned
- Prepare and review quality regulatory submissions for various markets to support timely approvals
- Maintain regulatory documents and support regulatory compliance
- Assess, coordinate, and compile deficiency responses
- Collaborate with functional areas to resolve submission-information issues
- Assess change-control documents and review change-control forms
- Maintain regulatory databases and trackers, including deficiency-response checklists, deficiency trackers, and submission spreadsheets
- Coordinate with third-party manufacturers regarding submission document requirements
- Provide backup support to team members
- Communicate and follow up with departments to compile and file submissions and query responses on schedule
- Interpret and ensure compliance with SOPs, regulatory affairs policies and procedures, and regulatory guidelines
- Prepare or draft SOPs and regulatory guidelines as applicable
- Discuss regulatory issues with internal departments and provide solutions
- Communicate with agents and suppliers to request or provide submission-related data
- Work safely and collaboratively to achieve outcomes
- Adhere to Global Business Ethics and Compliance, Global Quality, Safety and Environment, and HR policies
- Perform other relevant duties as assigned
Requirements
What you’ll need- Graduate/postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar
- Project Management qualification or knowledge is an additional advantage
- Minimum 4–7 years of experience in Core Regulatory Affairs in the US, Canada and/or EU
- Demonstrated knowledge of generic new product development processes and requirements
- Experience compiling dossiers for sterile injectables for key markets such as the US, Canada and EU
- Knowledge of technical, quality compliance, and global regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Experience influencing and coordinating complex regulatory activities with cross-functional teams and stakeholders
- Strong understanding of project management principles and practices in a complex environment
- Excellent oral and written English communication
- Experience with MS Office, particularly MS Word, MS Excel, and MS Project or other project-management software
Benefits
Comp & perks- Accommodation for applicants with disabilities as part of the recruitment process
- Welcoming and accessible work environment
- Support for applicants requiring interview or testing accommodations