Associate Director, Regulatory Affairs Job
Date: May 20, 2013
Location: Berkeley Heights, NJ, US
Job ID: 13786
Location: Berkeley Heights, NJ - 400
Full/Part Time: Full-Time
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
- BS or MS in scientific discipline or equivalent
- 5-9 years pharmaceutical industry with 3-5 years in regulatory.
- Advanced degree preferred.
Responsibilities will include, but are not limited to, the following:
- Manage regulatory aspects of Post-Marketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) [formerly the Division of Drug Marketing, Advertising and Communications (DDMAC)].
- Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Celgene’s products. Manage timelines and resources to achieve stated goals.
- Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Copy Review Committee (CRC). Foster and facilitate teamwork between GRA and these allied functions.
- Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases.
- Provide leadership for and manage regulatory aspects of the copy review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion.
- Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes.
- Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Celgene and FDA.
- Work closely with the GRA rep on Project Teams to support A&P Activities.
- BS or MS in scientific discipline or equivalent. Advertising and Promotional experience is a must.
- 5-9 years of pharmaceutical industry experience, including 3-5 years in regulatory affairs. Preference for at least 3 years experience in post-marketing regulatory affairs, specifically pharmaceutical promotional activity.
- Knowledge of Advertising and Promotional FDA regulations and experience with FDA communication and contact is necessary.
- Excellent interpersonal skills and written and oral communications skills.
- Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze, and solve problems with minimal supervisory input.
- Able to accommodate modest amount of domestic travel.
- Ability to manage multiple responsibilities with high degree of self-motivation.
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Nearest Major Market: New Jersey
Job Segments: Regulatory Affairs, Manager, Hematology, Oncology, Medical Technologist, Legal, Management, Healthcare