Medivation, Inc. (NASDAQ: MDVN – www.medivation.com), a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Regulator Associate/Manager, reporting directly to the Vice-President, .

The company is currently on a steep growth trajectory, with three programs in late stage clinical development targeting large, unmet medical needs.  Dimebon, the company’s lead molecule, is in a second, confirmatory Phase 3 trial in Alzheimer’s disease, and has also successfully completed a Phase 2 trial in Huntington’s disease.  The company’s second compound, MDV3100, is nearing completion of a Phase 1-2 trial in castration-resistant prostate cancer.

The Regulatory Affairs Senior Regulatory Associate/Manager will serve as Regulatory liaison for ex-US Clinical Trial Applications (CTAs) and promotional compliance of predevelopment projects. This individual will liaise with internal clinical operations and CMC teams, as well as external vendors, to ensure timely submission and maintainence of ex-US CTAs, including rapidly coordinating responses to regulatory authorities. The individual will be responsible for keeping abreast of regulations and guidelines in relevant countries, helping to maintain accurate regulatory files of communications with authorities. For promotional compliance activities, the individual will be responsible for reviewing, providing regulatory guidance on content and format external materials, and interacting on a multidisciplinary review team.

Minimum Requirements for position:

• Advanced degree (e.g., MS, PharmD, PhD);
• Minimum of 4 years of biotech and/or pharmaceutical experience, with 2 years experience with Regulatory Affairs;
• Experience in ex-US Clinical Trial Application management;
• Practical knowledge of regulations as applied to clinical trials;
• Scientific knowledge, with written a verbal communication skills;
• Project management skills (manage multiple projects and deadlines).

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.     Equal Employment Opportunity, M/F/D/V