Vice President Regulatory AffairsPosted: November 10, 2009
Vice President Regulatory Affairs Requisition ID 15086 Working Location Cambridge, MA Required Education Bachelors Degree Required Travel Yes Position Description Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success. Vice President, Regulatory Affairs Job Responsibilities/Department description: Reporting to the Senior Vice President, Regulatory Affairs & Corporate Quality, the Vice President, Regulatory Affairs will provide oversight and direction to the RA organizations responsible for global regulatory strategy, registration and post-marketing support for Genzyme products in the therapeutic areas of Cardiovascular, Metabolic/Endocrine, Renal and Solid Organ Transplant. The candidate will have a broad range of experience including all phases of the drug development and registration processes for both drugs and biologics. The candidate will have a proven track record in leading meetings with the U.S. Food & Drug Administration and in obtaining NDA/BLA approvals in the US (EU experience highly desirable). The candidate will also provide support for critical due diligence activities related to on-going licensing and acquisition opportunities. This highly committed, results-oriented individual must be innovative and forward-thinking, have demonstrated leadership skills, success in developing, mentoring and managing direct reports and be able to effectively manage the balance between delegation/empowerment and a hands-on approach. The ability to work successfully across functions and cultures in a highly matrixed, global organization is critical. Basic Qualifications: BA/BS with a minimum of 15 years industry experience 10+ years regulatory experience in the biotech/pharmaceutical industry At least five years in a senior leadership role managing a large group. Preferred Qualifications: Masters or other advanced degree preferred. Integrity and credibility; strong influencing and communication skills; solid scientific and product understanding; thorough knowledge of health authority regulations and industry guidance; experience in the relevant therapeutic are desirable as is active participation in industry trade associations.
Please refer to job code genzyme-72073 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> Regulatory Affairs
| | Location: | Cambridge, MA | | County: | Middlesex County | | ZIP Code: | 02138 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Genzyme | | Phone: | email only please | | Fax: | email only please |
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