Senior Director Regulatory CMC - Cell Therapy

Are you a highly experienced leader in the field of cell therapy with a deep understanding of regulatory CMC? Do you have a passion for driving innovation and ensuring compliance in the pharmaceutical industry? If so, Bristol-Myers Squibb may have the perfect opportunity for you. We are currently seeking a Senior Director of Regulatory CMC - Cell Therapy to join our dynamic team. In this role, you will be responsible for providing strategic direction and overseeing all regulatory activities related to cell therapy products. We are looking for a driven and knowledgeable individual who can navigate complex regulatory landscapes and shape the future of cell therapy at our company. If you have a proven track record of success in this area and possess the necessary qualifications, we invite you to apply for this exciting position.

• Develop and implement strategic plans for regulatory CMC activities related to cell therapy products
• Ensure compliance with all relevant regulations and guidelines, both domestically and internationally
• Act as the main point of contact for all regulatory CMC issues and provide guidance to cross-functional teams
• Stay up-to-date on emerging trends and changes in the regulatory landscape for cell therapy products
• Oversee the preparation and submission of regulatory documents, including INDs, BLAs, and variations
• Collaborate with internal and external stakeholders to ensure timely and accurate completion of regulatory submissions
• Lead interactions with regulatory authorities and participate in meetings and negotiations as needed
• Provide regulatory support for manufacturing, quality, and clinical development activities
• Monitor and assess potential risks and develop mitigation strategies to ensure successful regulatory outcomes
• Serve as a subject matter expert on regulatory CMC requirements for cell therapy products
• Mentor and develop junior team members and foster a culture of continuous learning and development
• Collaborate with cross-functional teams to drive innovation and shape the future of cell therapy at the company
• Represent the company at industry conferences and events to stay informed on industry best practices and trends.

According to JobzMall, the average salary range for a Senior Director Regulatory CMC - Cell Therapy in Summit, NJ, USA is between $200,000 and $250,000 per year. This range can vary depending on factors such as experience, education, and the specific company or industry. Additionally, bonuses and other benefits may also be included in the overall compensation package for this position.

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.