Senior Director - Regulatory CMC

Are you a driven and experienced leader in the pharmaceutical industry? Do you have a strong background in regulatory affairs and CMC (Chemistry, Manufacturing, and Controls)? If so, Bristol-Myers Squibb is seeking a Senior Director for our Regulatory CMC team. In this role, you will have the opportunity to lead a team and oversee all regulatory CMC strategies and activities for our global products. Our ideal candidate is a strategic thinker with extensive knowledge of regulatory guidelines and a track record of successful regulatory submissions. Join our dynamic and innovative team and make a meaningful impact on patients' lives.

1. Develop and implement regulatory CMC strategies for all global products in compliance with regulatory guidelines and company objectives.
2. Lead and manage a team of regulatory professionals, providing guidance and mentoring to ensure successful execution of regulatory CMC activities.
3. Review and approve all regulatory CMC submissions, ensuring accuracy, completeness, and timely filing.
4. Stay current with all relevant regulatory guidelines and industry trends, and provide guidance and recommendations to the company on potential impact to regulatory strategies.
5. Collaborate closely with cross-functional teams, including manufacturing, quality, and clinical, to ensure alignment and timely execution of regulatory CMC requirements.
6. Act as the primary point of contact for all interactions with regulatory agencies regarding CMC matters, including preparing and leading regulatory meetings and negotiations.
7. Identify potential risks and develop contingency plans to mitigate any potential delays or issues in regulatory CMC activities.
8. Ensure compliance with all relevant regulations and guidelines, including FDA, EMA, and other global regulatory agencies.
9. Serve as a subject matter expert on regulatory CMC matters, providing guidance and support to other departments within the company.
10. Continuously evaluate and improve processes and procedures related to regulatory CMC activities, in order to drive efficiency and effectiveness.
11. Represent the company at relevant industry conferences and events, and build relationships with key stakeholders in the regulatory community.
12. Provide regular updates to senior management on the status of regulatory CMC activities, including any potential risks or delays.
13. Act as a leader and mentor within the company, fostering a culture of continuous learning and development within the regulatory CMC team.

According to JobzMall, the average salary range for a Senior Director - Regulatory CMC in Princeton, NJ, USA is $175,000 to $225,000 per year. Salaries may vary depending on the specific company, years of experience, and education level. Additionally, bonuses and other benefits may also be included in the overall compensation package.

Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.