Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
Are you ready to play a critical role in bringing life-changing biologics and vaccines to patients worldwide? We're looking for a CMC Strategy Senior Associate / Consultant who thrives in a dynamic, collaborative environment and is passionate about shaping global regulatory strategies. In this role, you'll work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities. This is more than a delivery role-it's an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes.
What You'll Do
- 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 (Modules 1-3) for global submissions
- Perform CMC dossier gap analyses and provide clear, strategic recommendations
- Support and lead global submissions (US, EU, and beyond) from planning through execution
- Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders
- Act as a key contributor within a dedicated client team, building strong, trusted relationships
- Ensure submissions meet global regulatory expectations with precision and excellence
What You Bring
- 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years of experience for a Regulatory Affairs Consultant role
- Hands-on experience with commercial biologicals and/or vaccines (required)
- Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
- Proven experience in global submission management
- Expertise in authoring/reviewing CMC Modules 1-3 to support variations and performing gap analyses
- A collaborative mindset with strong communication and stakeholder management skills
- Experience with Veeva Vault (RIM/eCTD systems) is a plus
Why You'll Love This Role
- Dedicated Client Partnership: Build deeper relationships and drive long-term impact-not just project-based work
- Meaningful Work: Contribute to innovative biologics and vaccines that improve patient lives globally
- Global Exposure: Gain experience across US, EU, and international regulatory landscapes
- Growth & Influence: Be seen as a strategic partner and grow your expertise in a high-visibility role
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