CMC regulatory leader guiding biologics submissions and lifecycle compliance for Thermo Fisher Scientific. Managing FDA and Health Canada dossiers, changes, and post - approval reporting.
PA
Senior Regulatory Affairs Consultant – Post Approval CMC Authoring, Vaccines or Biologics
Posted 2 days ago
About the role
- CMC regulatory consultant guiding post-approval submissions and lifecycle management for biologics and vaccines. Parexel delivers clinical research and regulatory consulting solutions to the life sciences industry.
Responsibilities
- Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products
- Support and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments
- Author and review CMC documentation in Modules 1–3 for global submissions
- Perform CMC dossier gap analyses and provide strategic recommendations
- Lead and support global submissions from planning through execution
- Partner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders
- Assess regulatory impact of product, process, manufacturing, analytical, and control strategy changes
- Contribute within a dedicated client team and build trusted relationships
- Ensure submissions meet global regulatory expectations with precision, quality, and compliance
Requirements
- 5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role
- Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines
- Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products
- Experience with post-approval supplements, variations, manufacturing changes, process changes, analytical method updates, site transfers, specification changes, health authority commitments, or labeling-related CMC changes
- Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets
- Proven experience supporting global submission strategy and execution
- Expertise authoring and reviewing CMC Modules
- Experience performing CMC dossier assessments and gap analyses
- Strong communication, collaboration, and stakeholder management skills
- Ability to work directly with clients and cross-functional teams in a highly matrixed environment
- Preferred: experience supporting clinical development and commercial lifecycle management activities
- Preferred: experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities
- Preferred: experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems
- Preferred: advanced scientific degree (MS, PhD, PharmD, or equivalent)
Benefits
- Dedicated client partnership and strategic partnership work
- Meaningful work contributing to innovative biologics and vaccines that improve patient lives globally
- Global exposure across US, EU, and international regulatory landscapes
- Growth and influence through expanding expertise in biologics, vaccines, and post-approval CMC strategy
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Salary
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Degree requirement
No Education Requirement
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