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. Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
2. Lead global and/or regional regulatory team on assigned projects.
3. Develop and execute global and/or US regulatory strategy and contingencies for assigned projects.
4. Serve as the primary interface for FDA on assigned projects.
5. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross-functional teams to define contributions to submissions. Lead regulatory submission teams for projects assigned.
6. Prepare project/study team for FDA and other regulatory health agency meetings, as required.
7. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Development Teams and Study Teams, etc.
8. Represent regulatory in senior management discussions and present issues accordingly.
9. Interface with international affiliates on regional regulatory strategy and implementation plans.
10. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
11. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
12. Conduct Business Development diligence efforts, if assigned.
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-mediated diseases a plus.
A minimum of 10 years pharmaceutical industry with a minimum of 7 years in regulatory affairs. Global experience desirable.
Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
Demonstrated experience in preparing new IND and/or NDA submissions.
Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for 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.
Req ID: 15001945
Primary Location: United States-New Jersey-Warren
Job: Project Leadership and Portfolio Management
Organization: Celgene Corporation
Employee Status: Director
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2016-01-04 00:00:00.0
Business Development, Compliance, Healthcare, Law, Legal, Management, Manager, Medical, Pharmaceutical, Regulatory Affairs, Sales, Science