Director, CMC Regulatory Affairs

Pharmasset, Inc., located in Princeton, NJ, is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Our primary focus is on the development of oral therapeutics for the treatment of HBV, HCV and HIV. The company is focused on providing a work environment that fosters creativity with sufficient structure to develop new scientific breakthroughs, and offers a competitive salary and benefits program.

We are seeking an experienced, qualified person to join our Regulatory team in the role of Director, CMC Regulatory Affairs.

 Responsibilities Include:Develop, implement, and ensure the effectiveness of CMC regulatory strategy plans and regulatory submissions in support of corporate goals and objectives. Provide CMC regulatory support for ongoing development projects; assess and communicate requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Serve as the regulatory CMC representative on project teams and as the regulatory CMC contact with the FDA; foster relationships with internal project teams, business partners, and regulatory agencies. Collaborate with other development functions for timely preparation of high quality regulatory submissions, coordinate and manage the CMC sections of documents (INDs, NDA’s, etc.). Assure consistency and quality of submissions through technical guidance to team during strategy formulation and submission preparation. Evaluate analytical, manufacturing and/or packaging change controls, assess regulatory impact and support appropriate implementation. Interact with personnel at manufacturing sites and other key partners both internal and external to the company and provide CMC risk management (field audits, GMP inspections, etc.). Perform related duties, special projects and/or other functions as required.

 Qualifications Include:Bachelors degree in chemistry, chemical engineering or related scientific discipline is required; an advanced degree (PharmD, PhD or Masters in a science related discipline) is strongly preferred. Minimum of 8-10 years pharmaceutical industry experience (preferably in drug development or pharmaceutical sciences) with a minimum of 4 years in a regulatory affairs/CMC related role is required. Demonstrated up-to-date knowledge and expertise of global CMC regulatory principles and relevant FDA and ICH guidelines and regulations. Must be familiar with cGMPs. Proven ability to manage multiple, complex regulatory projects. Demonstrated success in the management of CMC regulatory submissions, including previous experience filing NDA’s, IND’s, amendments, etc. and interacting with regulatory authorities. Ability to work successfully with cross-functional teams and influence appropriate plans and actions. Candidate should be a highly motivated individual with demonstrated outstanding verbal and written communication skills, and have the ability and desire to work in a rapidly changing environment. Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.

 To Apply:

Send cover letter, resume and salary requirements to cmc5023hr@pharmasset.com and include the Position Code: CMC 5023 in the subject line of your email.

www.pharmasset.com

Pharmasset, Inc. is an Equal Opportunity Employer.