Director, Regulatory CMC Biologics (Cell Therapy) - United States
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following:
- Responsible for the development of the CMC regulatory strategy for our cell therapy submissions. These submissions include Health Authority Briefing Packages/IND/IMPD/BLA and MAA regulatory filings.
- Coordinate the preparation and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.
- Responsible for the regulatory evaluation of CMC change controls.
- Responsible for the management of CMC activities related to specific cell therapy developmental or commercial compounds.
- Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.
- Take on leadership role in the CMC cell therapy development/commercial teams.
- Interact with regulatory agencies and represent CMC at regulatory agency meetings.
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with
- 8-10 years in the pharmaceutical industry or in CRO, including 5-7 years CMC regulatory (biologics /cell therapy) experience. Cell therapy experience preferred
- Must have experience with CMC regulatory documents (MAA, CTD, BLA, supplements, responses and IND/IMPDs), with specific emphasis on cell therapy products
- Experience in the development of CMC regulatory strategy for cell therapy products
- Knowledge of FDA, EMA and ICH guidelines, especially for cell therapy products.
- Knowledge of rest of world post approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in either the cell therapy drug development process and in post approval activities
- Ability to work on complex projects and within cross-functional teams
- Prior supervisor or project management experience
- Experience with CMC regulations for cell therapy compounds.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.