Remotely
regulatory affairsregulatory submissionsr&dmentoringcmcall otherchange controlind/ctamanufacturing change records
Job Description
📋 Description
- Prepare CMC regulatory strategies under limited supervision
- Develop regulatory submissions for INDs/CTAs and amendments
- Support agency interactions and information requests
- Collaborate with RA, R&D, and Operations teams
- Mentor others and contribute to RA CMC initiatives
🎯 Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related field
- 6 years biopharmaceutical or related industry experience
- Experience in RA, R&D or operations in complex matrix environments
- Strong oral and written communication skills
🎁 Benefits
- Comprehensive benefits including PTO, medical/dental/vision
- Eligible for long-term incentive programs
- AbbVie equal opportunity employment
