WalthamFull TimeData Science
Remotely
regulatory affairsregulatory submissionscmcall otherfdactaindchange control
Job Description
📋 Description
- Regulatory Affairs (CMC) lead for regulatory strategies
- Prepare regulatory submissions and amendments (INDs/CTAs, variations)
- Collaborate with RA, Operations and R&D; liaise with agencies (FDA)
- Develop pre-meeting content and strategies for agency discussions
- Manage change control and product lifecycle regulatory requirements
- Mentor team members and drive RA CMC initiatives
🎯 Requirements
- Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related
- 8+ years pharma experience; 3+ years leadership
- 10+ years pharma with RA or related senior experience preferred
- Experience with global regulatory strategies and Health Authority interactions
- Strong written and oral communication; ability to work in matrix environments
🎁 Benefits
- Comprehensive benefits including PTO, medical/dental/vision
- 401(k) eligible; long-term incentive programs
- AbbVie equal opportunity employer; commitment to integrity and innovation
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