Senior Director, Biologics Global Regulatory CMC
6 days left
- Full Time
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:
1. Responsible for the development and implementation of the global CMC regulatory strategy for submissions. These submissions include IND/CTA, NDA, BLA and MAA regulatory filings.
2. Manage the multinational group responsible for local CMC filing activities in USA , EMEA, Japan , Latin America, Southeast Asia and Gulf Coast Region.
3. Responsible for the preparation and review global CMC submission documents, registration dossiers, and responses to health authorities. Approve CMC submission globally.
4. Responsible for the management of Global Regulatory CMC activities related to Celgene’s and partners investigational and commercial compounds.
5. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.
6. Interact directly with the FDA, EMEA, HPB, TGA and other global regulatory agencies on a regular basis. Represent regulatory CMC at regulatory agency meetings.
7. Participate in due diligence activities as it relates to the review of CMC submissions.
BS/BA degree in Scientific Discipline (Masters or higher preferred) with at least 15 years in the pharmaceutical industry or in CRO, including at least 10-12 years global CMC regulatory experience
Skills/Knowledge Required :
- Extensive experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
- Extensive experience in the development of a global CMC regulatory strategy
- Experience with CMC regulations for biological compounds
- Experience with Gene/Cell/CAR T Cell therapy CMC regulations
- Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
- Practical knowledge of rest of world post approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in the drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams
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.