Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)

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 / Regulatory Affairs 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 across both development and commercial products.

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 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 high-quality CMC documentation (Modules 1-3) for global submissions

• Perform CMC dossier gap analyses and provide clear, strategic recommendations

• Lead and support global submissions (US, EU, and international markets) 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

• Act as a key contributor within a dedicated client team, building strong, trusted relationships

• Ensure submissions meet global regulatory expectations with precision, quality, and compliance

What You'll Bring

Required Qualifications

• 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 (required)

• Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products, including one or more of the following:

  • Post-approval supplements

  • Variations

  • Manufacturing changes

  • Process changes

  • Analytical method updates

  • Site transfers

  • Specification changes

  • Health authority commitments

  • 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 Qualifications

• Experience supporting both clinical development and commercial lifecycle management activities

• Experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities

• Experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems

• Advanced scientific degree (MS, PhD, PharmD, or equivalent)

Why You'll Love This Role

Dedicated Client Partnership

Build deeper relationships and drive long-term impact through a strategic partnership rather than 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 while supporting global product portfolios.

Growth & Influence

Be recognized as a strategic regulatory partner while expanding your expertise in biologics, vaccines, and post-approval CMC strategy.

Ready to Make a Difference?

If you have experience supporting approved biologic and/or vaccine products through post-approval regulatory submissions and lifecycle management activities and are looking for a role where your expertise is valued, your voice is heard, and your work truly matters, we'd love to hear from you.

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