Job: Senior Director, Regulatory Affairs - Advertising & Promotion

Jobing Description

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: Senior Director, Regulatory Affairs - Advertising & Promotion

Reports to: Senior Vice President, Global Head, Regulatory Affairs & Compliance
Job Responsibilities/Department description:

You will be responsible for directing the regulatory aspects of External communications including Advertising and Promotional activities for all products in the company as well as the recruitment and management of a staff of regulatory affairs ad/prom professionals. Product portfolio includes multiple products serving patients with rare and genetic diseases as well as two products currently pending registration in the area of multiple sclerosis and three new products completed phase III and nearing registration and commercialization. Responsible for leading the group charged with reviewing external communications materials, sales and marketing, training and product promotional strategies for compliance to current regulations and guidance. Will represent the regulatory department with corporate senior management and provide advice on regulatory issues specific to external communications that affect the businesses of the company. Represent the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to Advertising and Promotional activities. You will work closely with senior personnel in Regulatory Affairs, Marketing, Corporate Communications and Legal to support commercial interests and registration activities of the business. Participate in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations. Provide strategy and risk assessment analysis to business units and senior management. Develop long- and short-term planning and supervision of regulatory projects which impact the company's business plan. Candidate will be responsible for taking lead in development and oversight of the processes and procedures relevant to the creation, review and approval of advertising and promotional materials and other external communication to ensure regulatory compliance. The position is part of the global regulatory affairs and compliance organization but has a primary focus on support of the business in the United States.

Qualifications

Basic Qualifications:
The successful candidate will have a minimum of:

* BS Degree

* 7-10 years knowledge and experience in promotional labeling and advertising regulations in the biotech/pharmaceutical industry

* 5 years in a leadership role as a highly effective people manager

* Direct experience communicating and negotiating with DDMAC

Preferred Qualifications:

The ideal candidate will have:

* BS in Life Sciences or Masters Degree or JD
* Proven experience practicing sound judgment as it relates to risk assessment

Job
: Regulatory Affairs

Primary Location
: United States-Massachusetts-Cambridge

Job Posting
: Nov 23, 2011

Shift
: Day Job

Job Type
: Regular

Employee Status
: Regular