- Sr. Regulatory Affairs Manager
Summary:
The Sr. Regulatory Affairs Manager will support global regulatory activities for pharmaceutical products and ensure compliance with applicable regulatory requirements.
Responsibilities:
- Develop and execute regulatory strategies for product lifecycle 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.
- Support change controls and regulatory impact assessments.
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.
