Asc Dir / Dir, US Reg Ops, CMC

Wyeth Consumer Healthcare is a worldwide leader in the research, development, and marketing of innovative products, including three of the five top selling OTC brands in the U.S.: Advil®, Robitussin®, and Centrum®.We currently have a career opportunity at our Richmond,VA location for an Associate Director/Director, US Regulatory Operations - CMC within our Scientific Affairs department.The primary responsibilities are to manage the U.S. Regulatory CMC-related process to achieve high quality, timely regulatory filings and approvals. Manages and directly contributes to the completion of CMC-related regulatory activities and processes for product development and post approval product life cycle maintenance. Develops, communicates and implements CMC-related regulatory strategies consistent with U.S. product development, registration and commercialization strategies. Ensures CMC information in NDA/IND submissions meets FDA standards for registration and clinical trial applications. Provides direction for U.S. CMC submissions and recommends best regulatory position to achieve desired outcome in the shortest time. Represents U.S. Regulatory CMC Operations at departmental, project team and professional meetings.Additional responsibilities include:
Evaluate and prospectively resolve technical, regulatory and quality issues that could impact on submissions (IND, NDA) and approval (NDA) of the CMC documentation.

Provide high quality input on CMC regulatory requirements for development and approval of new products and for life cycle management of approved products.

Communicate submission requirements and subsequent filing commitments as appropriate.

Generate high quality, timely responses to Health Authority questions to resolve any CMC issues related to approval status.

Ensure compliance to relevant regulations and standards (e.g. CFR, USP, CPSC, GMP, etc.); monitor and effect appropriate action in response to changes in these standards.

Lead interactions and negotiations with local Health Authorities and company facilities on CMC issues to ensure rapid preparation and approval of submissions.

Ensure timely and effective regulatory input into Change Control proposals and activities. Support evaluation of Change Requests. Generate high-quality CMC documentation for obtaining rapid and advantageous registrations of change or for routine maintenance of approved products.Position Requirements:
Bachelor's degree in Chemistry, Pharmacy or a related science field plus 8-10 years of relevant experience industrial experience in the healthcare industry. Alternatively, an MS/PharmD or PhD plus 4-8 years of relevant experience industrial experience in the healthcare industry. The ideal candidate will have a minimum of 4-5 years of hands-on CMC and submissions-related experience. Candidates with no prior CMC and submissions-related experience will not be considered unless they have 4 years of hands-on experience as a Subject Matter Expert and Technical Writer generating submission components and related documentation for regulatory filings.

Working knowledge of chemistry, analytical and pharmaceutical technology and of the drug development process. Ability to critically evaluate data from a broad range of scientific disciplines.

Knowledge/experience of US regulations, guidances and regulatory processes for development products and product life cycle maintenance.

Prior experience with regulatory submissions and/or document management and publishing systems is highly preferred. Prior experience with document publishing software is highly preferred.

Excellent and effective planning, organizational, and interpersonal skills.

Ability to work successfully with extended project teams and influence others in a matrix organization.

Ability to plan, coordinate and lead CMC activities simultaneously on multiple projects under pressure of time.Please email your resume to