Sr. Regulatory Affairs Manager
On-site · North Carolina, United States
North Carolina, United StatesOn-siteFull TimeSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Lead global regulatory strategies for pharmaceutical products, develop and execute lifecycle regulatory activities, prepare and review regulatory submissions and documentation, support communications with regulatory agencies globally, ensure compliance with FDA, EMA, and international regulatory requirements, collaborate cross-functionally with Quality, Manufacturing, R&D, and Supply Chain teams, and support change controls and regulatory impact assessments.
Required Qualifications
- Bachelor’s degree in Life Sciences or related field
- 8+ years of Regulatory Affairs experience in pharmaceutical manufacturing
- Strong knowledge of FDA and EMA regulations
- Experience supporting global submissions and post-approval changes
- Excellent communication and project management skills
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