Regulatory Affairs Associate Principal CMC Job Listing at Genzyme Corporation in Framingham, MA

Biotechnology, Pharmaceutical

Regulatory Affairs Associate Principal - CMC-30887

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).

We are looking for a motivated Regulatory Affairs professional to join our RA-CMC group supporting Fabrazyme (agalsidase beta).

Working under general supervision, the successful candidate will be responsible for the coordination and preparation of document packages for regulatory submissions or documentation and inspections by ensuring compliance with required regulations and interpretations. Communicates with outside regulatory agencies regarding submissions and acts as a liaison between internal departments. Works independently to review technical documentation and recommends/approves changes in testing and manufacturing for regulatory compliance ensuring conformance with existing regulatory approvals. Reviews regulatory information and data and participates in the development of new regulatory strategies. Interacts with senior external personnel on significant technical matters, often requiring coordination between organizations.

Qualifications

Basic Qualifications:

- Bachelor's degree with 5 years experience in a Regulatory Affairs experience related role, or

- Master's degree with 3 years experience in a Regulatory Affairs related role, or

- PhD with 2 years experience in a Regulatory Affairs related role.

Prefferred Skills:

- ability to work independently with moderate supervision

- excellent writing and presentation skills,

- ability to communicate and interact with all levels of management

- flexible when priorities change, ability to complete tasks with a sense of urgency

- excellent negotiation skills and ability to present a different opinion in a pleasant manner

- familiarity with IRIS database and Trackwise database a plus,

- Microsoft Excel and Word proficiency required.

Job : Regulatory Affairs
Primary Location : United States-Massachusetts-Framingham

Job Posting : Jan 14, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular