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.
BS/BA degree in Scientific Discipline (Masters or higher preferred) with
a minimum of 7 years in the pharmaceutical industry, with a minimum of 5 years CMC regulatory (biologics preferred) experience.
Responsibilities will include, but are not limited to, the following:
Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings. Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions. Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required. Responsible for the management of CMC activities related to specific developmental or commercial compounds. Responsible for the regulatory evaluation of CMC change controls. Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams. Take a leadership role in the CMC development/commercial teams. Maintain knowledge of global regulatory environment, regulations and procedures.
#LI-POSTCelgene 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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.