Vice President, Regulatory Affairs, CMC

Vice President, Regulatory Affairs, CMC

Requisition ID 15229 Working Location Framingham, MA Required Education See Description 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 CMC Job Responsibilities/Department description: This is a critical senior regulatory position in the corporation. The Vice President, Regulatory Affairs -Chemistry, Manufacturing & Controls (CMC) will direct the RA-CMC organization responsible for global CMC regulatory strategy and support for all Genzyme therapeutic products, to include protein and small molecules, as well as cell and gene therapy products. The successful candidate will be Genzymes leading external representative to PHRMA, BIO, and other key trade organizations. In addition, they will be internally responsible for assuring that Genzyme is an industry leader and innovator in CMC strategy. The successful candidate will assure that not only are CMC submissions of the highest quality, but that submissions management (original marketing applications and CMC supplements/variations), change control, and global CMC compliance are managed through efficient and well-understood processes. She or he will assure that these activities are accomplished with disciplined budgeting and forecasting of required resources, and will be accountable to all business units for same. The successful candidate will represent Genzyme to global regulatory agencies as necessary, and assure that leaders within the RA-CMC organization are appropriately trained for critical regulatory agency interactions. Key objectives for this position include critical support of capacity planning and global manufacturing expansion, to conclude with successful and timely approvals of new sites and processes for all products, thus assuring maintenance of market supply. Finally, the successful candidate will also provide support (or assure support within the RA-CMC organization) for critical due diligence activities. Basic Qualifications: BA/BS with a minimum of 15 years industry experience 10+ years CMC regulatory experience in the biotech/pharmaceutical industry, including biologics experience. At least five years in a senior leadership role managing a large group. Preferred Qualifications: PhD preferred. Direct FDA review experience is highly desirable. Leadership of an expanding global RA-CMC organization is critical as well as a strong reputation within the industry and demonstrated leadership skills. 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. The candidate will have a broad range of experience in regulatory CMC aspects across all therapeutic platforms, including extensive biologics experience. Direct FDA review experience is highly desirable. The candidate will be innovative and forward-thinking in the regulatory CMC arena, as demonstrated by active participation in strategic industry initiatives around global CMC regulatory issues.

Please refer to job code genzyme-72079 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Framingham, MA
County:	Middlesex County
ZIP Code:	01701
Pay Rate:	Open
Job Terms:	full time
Company:	Genzyme
Phone:	email only please
Fax:	email only please