Regulatory Affairs Director
3 weeks ago
Stirling Q&R is seeking an accomplished and results-driven Senior Manager of Regulatory Affairs to lead the efforts in developing and executing regulatory strategies for our client's product portfolio.
Key Responsibilities:
- Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
- Provide regulatory guidance to cross-functional teams on a wide range of issues.
- Anticipate and resolve potential regulatory challenges consistent with business objectives.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, NDAs, BLAs, and their international equivalents.
- Respond to and manage health authority queries/information requests.
- Guide interactions with regulatory agencies, including FDA and EMA.
- Prepare for and participate in key regulatory meetings.
- Establish and maintain positive relationships with regulatory authorities.
- Mentor junior Regulatory Affairs professionals and emphasize continuous improvement and Regulatory excellence within the team.
Requirements:
- Advanced degree in life sciences preferred (Ph.D., Pharm.D. or M.D.).
- Minimum of 8-10 years pharmaceutical industry experience in Regulatory Affairs, with at least 3 years in a supervisory role.
- Strong understanding of regulatory requirements of FDA, EMA, and ICH throughout the product development process.
- Proven track record of successful submissions and approvals with excellent project management, communication, and leadership skills.
Benefits:
- Competitive compensation package, including attractive base salary, annual bonus, comprehensive health and wellness benefits, 401(k) plan company match, generous paid time off, and holidays.
- Professional development opportunities.
This is a great opportunity to make a real difference in the lives of patients while taking your career to the next level in a supportive and innovative environment.
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