Associate Director/Director – Regulatory Affairs CMC, 1200-03B

Vertex Pharmaceuticals Incorporated is a global biotechnology company focused on the discovery, development and commercialization of breakthrough drugs for a range of serious diseases. Our business strategy is to commercialize major new drugs both independently and in collaboration with other pharmaceutical companies.

 

Associate Director/Director ? Regulatory Affairs CMC, 1200-03B

 

In this position, you will be responsible for developing and directing/implementing innovative global regulatory CMC strategies. The selected candidate will direct the planning and coordination of clear and effective regulatory CMC/Quality submissions and CMC meetings with regulatory health authorities, develop and implement innovative global regulatory CMC strategies, and recommend regulatory policies to ensure adherence to global regulatory CMC requirements.

 

Ideal applicants would have a Ph.D. in chemistry and 5-8 years of experience in a Regulatory CMC role in a pharmaceutical company that develops small molecule drugs or biotech compounds. The candidate will ideally have started their pharmaceutical career in a CMC development role (e.g., Formulation Development, Process Chemistry, Analytical Development) before moving into Regulatory Affairs, and will have directly contributed to a successful NDA submission.

 

We provide a highly stimulating working environment coupled with a high level of professional and intellectual challenge. In addition to a competitive salary and benefits, we also offer equity participation and participation in a stock purchase program.

 

Apply online at www.vrtx.com

 

EOE