Celgene Associate Director, Regulatory Affairs 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:
Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
Lead global and/or regional regulatory team on assigned projects.
Develop and execute US regulatory strategy and contingencies for assigned projects.
Serve as the primary interface for FDA on assigned projects.
Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
Prepare company team for FDA and other health agency meetings, as required.
Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases a plus.
5-9 years pharmaceutical industry experience, including 3-5 years in regulatory affairs. Global experience desired.
Thorough knowledge of the drug development process, IND and NDA process.
Demonstrated experience in preparing FDA submissions.
Inter-dependant partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail.
Domestic and occasional International travel may be necessary.
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 Affairs
Location: Summit, NJ, US
Job ID: 17001805