Senior Regulatory Affairs Associate tracking global regulations and leading impact assessments. Supporting Parexel’s clinical research and life sciences consulting solutions through regulatory intelligence.
About the role
- CMC regulatory consultant shaping global biologics and vaccine submissions for Parexel’s clinical development services. Leading lifecycle strategy, Modules 1-3 documentation, and dossier gap analyses.
Responsibilities
- Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes
- Author and review high-quality CMC documentation for Modules 1-3 for global submissions
- Support and lead global submissions in the US, EU, and beyond from planning through execution
- Perform CMC dossier gap analyses and provide clear, strategic recommendations
- Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders
- Act as a key contributor within a dedicated client team and build strong, trusted relationships
- Ensure submissions meet global regulatory expectations with precision and excellence
- Influence CMC regulatory strategy and regulatory outcomes as a trusted advisor
- Contribute to lifecycle management activities and long-term client partnerships
Requirements
- 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role
- 5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role
- Hands-on experience with commercial biologicals and/or vaccines
- Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets
- Proven experience in global submission management
- Expertise in authoring and reviewing CMC Modules 1-3 to support variations
- Experience performing CMC dossier gap analyses
- Strengths in CMC regulatory strategy, CMC Modules 1-3 authoring and review, and dossier gap analysis
- Experience in CMC Regulatory Affairs or CMC Strategy within a regulated biopharmaceutical environment
- Ability to collaborate across teams, manage stakeholders, and communicate clearly
- Patient-focused mindset, commitment to quality and integrity, and strong attention to detail
- Comfort working with global submission processes and regulatory documentation standards
- Experience with Veeva Vault (RIM/eCTD systems) preferred
- Candidates must be located in Canada; flexibility to work Eastern Time hours is required for candidates outside Canada's eastern time zone
Benefits
- Comprehensive benefits package for eligible employees
- Competitive salaries based on position and level offered, skills, education, training, experience, professional achievements, and location
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs
- Flexibility, growth, and space to do their best work
- Continuous learning opportunities
- Global exposure across US, EU, and international regulatory landscapes
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
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