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ms office regulatory affairs cmc ind ctas📋 Description
- Serves as regulatory CMC representative on project teams.
- Reviews proposed CMC changes and regulatory impact.
- Supports filings (INDs, CTAs, BLAs, NDAs).
- Collaborates on submission content for regulatory clarity.
- Ensures timely preparation of organized and scientifically valid applications.
- Travel up to 15% may be required.
🎯 Requirements
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or related field.
- Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
- 0-2 years of experience in Regulatory Affairs.
- Strong written and verbal communication, organizational and people skills.
- Experience with regulatory submissions (INDs, CTAs, BLAs/NDAs) and lifecycle management.
- Ability to travel up to 15%.
🎁 Benefits
- Competitive compensation with base salary and annual bonus.
- Flexible PTO, holidays, and parental leave.
- Healthcare benefits with HSA matching and 401k matching.
- Employer-paid life and disability insurance.
- Pet insurance and wellness discounts.
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