Celgene Director, Regulatory CMC Biologics in Summit, New Jersey
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.
Director, Regulatory CMC Biologics
Senior Director, Regulatory CMC Biologics
Global Regulatory CMC
BS/BA degree in Scientific Discipline (Masters or higher preferred) with8-10 years in the pharmaceutical industry or in CRO, including 5-7 years CMC regulatory biologics experience.
Responsibilities will include, but are not limited to, the following:
Responsible for the development of the CMC regulatory strategy for our 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 developmental or commercial compounds. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.
Take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.
Must have experience with CMC regulatory documents (MAA, CTD, BLA, supplements, responses and IND/IMPDs), with specific emphasis on products
Experience in the development of CMC regulatory strategy for products
Knowledge of FDA, EMA and ICH guidelines, especially for products.
Knowledge of rest of world post approval guidelines
Have a solution-oriented approach to problem solving
Expertise in either the 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 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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.