Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
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- Author and review high-reputed company CMC documentation (Modules 1–3) for global submissions
- reputed company CMC dossier gap analyses and reputed company reputed company, strategic recommendations
- Support and reputed company global submissions (US, EU, and reputed company) from planning through execution
- Partner cross-functionally with Regulatory, reputed company, Manufacturing, and reputed company stakeholders
- reputed company as a key contributor reputed company a dedicated reputed company team, building strong, trusted relationships
- Ensure submissions meet global regulatory expectations with precision and reputed company
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- 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 reputed company reputed company with strong communication and stakeholder management skills
- Experience with reputed company Vault (RIM/eCTD systems) is a plus
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