Mgr/Asc Dir, Regulatory Ops

Wyeth Consumer Healthcare is a worldwide leader in the research, development and marketing of innovative products, including three of the top selling OTC brands in the US: Advil®, Robitussin® and Centrum®.Our success is built on strong, caring leadership, a commitment to fostering long-standing customer relationships, and a continuous stream of innovative products. It all adds up to the ideal environment for self-motivated, enthusiastic professionals who are not content to rest on past achievements, but instead are always seeking new challenges.We currently have a career opportunity at our Madison, NJ headquarters for a Manager / Associate Director - Regulatory Operations, CMC.The primary responsibilities are to perform U.S. Regulatory CMC-related activities to achieve high quality, timely regulatory filings and approvals. Directly contributes to the completion CMC-related regulatory activities and supports processes for product development and post approval product life cycle maintenance. With managerial input and guidance, 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. With managerial input and guidance, provides direction for U.S. CMC submissions and communicates regulatory recommendations to achieve desired outcome in the shortest time. As requested by management, can represent U.S. Regulatory CMC Operations at departmental, project team and professional meetings. Position is in Madison and is an individual contributor.Additional Key Responsibilities Include:
Evaluating and resolving 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.

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.

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.

Provide regulatory guidance, strategy and advice to project teams for products in development and resolve CMC-related regulatory issues for products in development and post-approval. Identify trends and changes in the CMC regulatory environment and communicates to Regulatory Management.

Review documentation including SOPs, material specifications and stability protocols, among others. Writes regulatory SOPs as required.
Provide support as needed to international registration activities and participate in internal and external committees (Wyeth, CHPA, USP, etc.).
Provide regulatory assessments in response to internal and external inquiries regarding regulatory requirements.

Participates in decisions and provides input regarding the adequacy, accuracy, interpretation, and clarity of technical information/reports prepared by plant functional groups to support submission-related activities.

Act as a key interface with the FDA and several resources.Qualifications:
The qualified candidate will have a minimum of a Bachelor's degree in Chemistry, Pharmacy or a related science field plus 3-5 years of relevant experience industrial experience in the healthcare industry. Alternatively, an MS/ PharmD or PhD plus 3-5 years of relevant experience industrial experience in the healthcare industry.

The ideal candidate will have a minimum of 2-3 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 2-4 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 is required

Ability to critically evaluate data from a broad range of scientific disciplines is required

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

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

Prior experience with document publishing software is highly preferred.

Ability to plan, coordinate and lead CMC activities simultaneously on multiple projects under pressure of time is required

Prior U.S. Regulatory Experience, knowledge of applicable regulations, and current Industry Practices is required.

Technical writing and review of U.S. Submissions and FDA communications is strongly preferred.

Organization of CMC Submission Related Activities (IND/NDA, and pre-Approval Inspection Readiness)

The qualified candidate will have excellent oral and written communication skills, planning, problem solving, organizational, collaborative and interpersonal skills and have the ability to work successfully with extended project teams and influence others in a matrix organization.Please email your resume to