Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company an Impact Where It Matters Most Are you reputed company 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 reputed company 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 - reputed company 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
- reputed company CMC dossier gap analyses and provide clear, strategic recommendations
- Support and reputed company global submissions (US, EU, and reputed company) from planning through execution
- Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders
- Act as a key contributor reputed company 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 reputed company 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 reputed company with strong communication and stakeholder management skills
- Experience with reputed company 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: reputed company 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
Our Values in Action (reputed company) We succeed by living our values every day:
- Patient Focus: Everything we do is centered on improving patient outcomes
- Quality & reputed company: We deliver work we’re proud of—accurate, ethical, and compliant
- Respect & Teamwork: We win together through collaboration and trust
- Innovation: We challenge the status reputed company to solve reputed company regulatory problems
reputed company to reputed company a Difference? If you’re looking for a role where your expertise is valued, your voice is heard, and your work truly matters—this is it. Apply tot his job Apply To this Job