Celgene Associate 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.
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.
BS/BA degree in Scientific Discipline (Masters or higher preferred) with a minimum of 7 years in the pharmaceutical industry, and a minimum of 5 years CMC regulatory (biologics preferred) experience.
Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.
Thorough knowledge of FDA, EMEA and ICH guidelines.
Knowledge of rest of world pre- and post-approval guidelines
Have a solution-oriented approach to problem solving
Expertise in the biologic drug development process and post approval activities
Ability to work on complex projects and within cross-functional teams
Prior supervisor or project management experience
Experience with global CMC regulations for biological 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.
Associate Director, Regulatory CMC, Biologics
Location: Summit, NJ, US
Job ID: 17001240