AbbVie

10,001+ employees
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Associate Director, RA CMC

Added

2 hours ago

Location

🇬🇧 Waltham

Type

Full time

Salary

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Related skills

regulatory affairs regulatory submissions fda cmc change control

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📋 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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