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Senior Regulatory Affairs Specialist
Posted 24 days agoViewed
💎 Seniority level: Senior, 5+ years
📍 Location: United States, Canada
🔍 Industry: Life Sciences, Pharmaceutical
🗣️ Languages: English
⏳ Experience: 5+ years
Requirements:
- 5+ years in the pharmaceutical industry
- 2+ years in Regulatory-CMC
- Experience authoring CMC sections in regulatory filings
Responsibilities:
- Author and review CMC regulatory documents
- Perform assessment of CMC changes
- Manage regulatory operational activities
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🔥 Senior Regulatory Affairs Specialist
Posted 3 months ago
📍 United States, India
🔍 Life sciences consulting
🏢 Company: Syner-G
- A Bachelor’s degree in a health or life science discipline is required; advanced degree preferred.
- 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
- 2+ years of experience in Regulatory-CMC.
- Ability to read and interpret technical documents and health authority regulations.
- Familiar with Common Technical Document (CTD) formatting and working knowledge of US and European regulations.
- Author and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings).
- Perform assessment of CMC changes and identify global regulatory requirements.
- Compile documentation for regulatory submission packages including license renewals and market registration.
- Ensure compliance with FDA, EMA, and global regulatory requirements.
- Work with multiple regulatory systems and tools during the end-to-end submission process.
Posted 3 months ago
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