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Senior Analyst – Product Life Cycle Management
Apotex Inc.. Support preparation of new product submissions and product life-cycle management for Apotex products in US and Canada markets .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions and product life-cycle management, with a strong focus on compliance and collaboration across departments. Proficient in preparing and maintaining documentation for regulatory processes in the US and Canada markets.
Highest-signal resume keywords
Regulatory SubmissionsProduct Life-Cycle ManagementChange Control DocumentationSOP PreparationRegulatory Compliance
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 SubmissionsProduct Life-Cycle ManagementChange Control DocumentationDossier CompilationRegulatory Guidelines Interpretation
Soft Skills
CollaborationCommunicationTeamworkProblem-Solving
Tools & Technologies
Regulatory DatabasesDocumentation Management Systems
Industry Keywords
PharmacyChemistryLife SciencesGlobal Business EthicsCompliance
About the role
Key responsibilities & impact- Support preparation of new product submissions and product life-cycle management for Apotex products in US and Canada markets
- Prepare submission and approval notifications for applications submitted to US and Canadian regulatory agencies
- Maintain documentation and database records for approved products
- Prepare and review quality regulatory PLCM submissions for US and Canada markets
- Support preparation of new product development submissions
- Maintain regulatory documents to support compliance
- Prepare pre- and post-approval supplements for regulatory product life-cycle management
- Assess change control documents and review change control forms
- Maintain regulatory databases and trackers for NPD, PLCМ, deficiency responses, and submissions
- Coordinate with third-party manufacturers regarding regulatory submission documents
- Provide backup support to team members
- Communicate and follow up with departments to compile and submit PLCM submissions and query responses
- Prepare or draft SOPs and regulatory guidelines as applicable
- Collaborate with internal departments to resolve regulatory issues
- Communicate with agents and suppliers to request or provide submission data
- Work safely and collaboratively to achieve outcomes
- Demonstrate Apotex values of Integrity, Teamwork, Courage, and Innovation
- Perform other relevant duties as assigned
Requirements
What you’ll need- A Post-graduate/Graduate degree in Chemistry, Pharmacy, or Life Sciences
- Knowledge of pre- and post-approval change submission requirements
- Experience compiling new dossier/variation packages for US, Canada, Europe, Australia, and New Zealand markets
- Minimum 1 year of experience in US, Canada, Europe, Australia, and New Zealand markets
- Knowledge of regulatory submissions and product life-cycle management
- Ability to interpret and comply with SOPs, regulatory affairs policies and procedures, and regulatory guidelines
- Commitment to Global Business Ethics and Compliance, Global Quality, Safety and Environment, and HR policies
Benefits
Comp & perks- Accommodation for applicants with disabilities as part of the recruitment process
- Welcoming and accessible work environment
- Supportive workplace where employees feel valued and respected