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 energetic, 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 BringRequired 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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📌 Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics) at Parexel (India)
🏢 Parexel
📍 India