Careers at Pharmasset

• 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.
• Perform related duties, special projects and/or other functions as required.

• 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.

Pharmasset, Inc. is an Equal Opportunity Employer.