Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html
The position is responsible for managing Regulatory Affairs activities (nonclinical, clinical and safety) for assigned investigational development products from preclinical candidate designation through product approval, including regulatory submissions. This individual is responsible for maintaining an in-depth awareness of relevant federal and international regulations and policies to optimize Astex’s regulatory input to assigned projects and teams.
Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
Manage the preparation, review and assembly of regulatory submissions and oversee the maintenance of regulatory filings to support global clinical trials (i.e., initial INDs, CTAs, amendments, safety updates, and Annual Reports).
Review clinical trial related documents including clinical protocols, informed consent forms, investigator brochures, clinical labels, safety management plans.
Assist in the preparation and review of regulatory filings to support U.S. marketing applications (i.e., NDAs).
Collaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, NDAs, meeting packages, response to queries, supplements, annual reports)
Provides expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams
Other tasks and responsibilities as directed by the Regulatory Affairs team
Maintain up-to-date knowledge of current regulations for applicable territories
Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.
Bachelor’s degree in a relevant discipline
Minimum of 5 years of pharmaceutical Regulatory Affairs experience
Knowledge of the drug development process, drug laws, and global regulations and requirements is required
Experience with submitting and managing global clinical trial applications required
Familiarity with eCTD and Sharepoint
Proficiency accessing documentation utilizing multiple electronic systems
Strong communication, project management and interpersonal skills are essential
Employer will assist with relocation costs.
Internal Number: 19-07R
About Astex Pharmaceuticals
Our corporate mission is to discover and develop novel therapeutics with a primary focus in cancer and a developing focus in CNS disorders.