Manager/Associate Director CMC

Responsible for development and execution of Regulatory plans (filing strategies, preparation, submission and approval) of the Chemistry, Manufacturing, and Controls sections of ANDAs for the company's products as well as maintenance of CMC sections of ANDAs, annual reports and supporting the international registration of company's product line. Communicate with FDA regarding the submission and approval of CMC dossiers for the assigned projects. Liaise with internal departments (Research, Manufacturing and Product Development and QA/QC) and external business partners regarding Regulatory compliance activities (change control management). Provide counsel and interpretation of regulations and guidances to the company's project teams.

Experience:
Requires a Masters Degree in Biology, Chemistry, Engineering or Pharmacy; Ph.D. a plus. Five plus years of regulatory CMC experience, including the preparation of CMC dossiers. Ten plus years of pharmaceutical experience in biologics manufacturing, pharmaceutical development or QA. Knowledge of international regulatory requirements for biologics is preferred. The candidate will have a broad technical foundation and a good understanding of generic product development process. Ability to interpret current and proposed FDA regulations/guidelines and ICH guidelines is essential.