Associate Director Regulatory Affairs - Advertising and Promotion

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).Job Title: Associate Director Regulatory Affairs- Advertising and Promotion

Job Responsibilities/Department description:The Associate Director, Advertising and Promotion will be responsible for directing the regulatory aspects of review and approval of promotional materials and marketing activities for new products and/or acquisitions. The successful candidate will be responsible for providing regulatory leadership to the respective team charged with advertising and promotion review to ensure compliance of promotional materials and communications with FDA regulations and company policies. This position will provide regulatory compliance support for existing and new therapeutic areas, including Renal and Endocrine and will provide regulatory representation on the Promotional Review Boards. You will serve as the primary contact leading and facilitating communications with the Division of Drug Marketing and Communications (DDMAC) and direct the timely submission of all applicable approved promotional materials to the FDA on Form 2253. The candidate will manage the maintenance of records and databases that support communication with DDMAC.

The Associate Director will also deliver Regulatory compliance training. You will be responsible for participating in developing processes and procedures relevant to the creation, review and approval of advertising promotional and labeling materials and other external communication with references to regulatory compliance.
Basic Qualifications:The successful candidate will have a BS Degree and 5 years industry regulatory experience including knowledge and experience with promotional and advertising regulations. The ideal candidate will have experience communicating and negotiating directly with DDMAC. Must have strong leadership skills be able to influence others and foster team collaboration.
Preferred Qualifications:
PHRMD, JD or MS in scientific discipline