Manager, Regulatory Affairs
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. Work with Global Regulatory Strategy Leader, US Regulatory Strategy Leader and product Regulatory Team to implement plans for identified projects in development.
2. Manage the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. May lead regulatory submission team for projects assigned.
3. Provide input to the regional regulatory development and submission strategies, as assigned.
4. Participate or act as regulatory representative on various cross-functional teams, as assigned.
5. Participate or lead regulatory interactions with FDA, as assigned.
6. Work with Regulatory Operations to prepare FDA submission documents in electronic format.
7. Maintain knowledge on the US competitive landscape, regulatory environment, regulations and guidances.
8. Become knowledgeable with European Regulatory laws/guidances.
9. Provide Regulatory Research and Intelligence support for team as assigned.
Bachelors in scientific discipline: 3-5 years pharmaceutical industry experience. Advanced degree preferred.
Skills/Knowledge Required: ? Bachelor’s degree in scientific discipline; advanced scientific degree preferred. ? Experience in multiple phases of drug development. Experience in inflammatory and immune diseases a plus. ? 3-5 years pharmaceutical industry experience. ? Good understanding of the drug development process. ? 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.