Director Medical Device Regulatory CMC Pfizer Andover

Job Description: • 2-minute read •
Drug delivery device and combination product regulatory support. The Reg-CMC Medical Device Strategist works as part of a global group responsible for developing global regulatory strategies and preparing regulatory submissions for Pfizer’s device and combination products across the product lifecycle.

The primary function will be to provide strategic direction to DCoE and device related project teams who are leading development of Pfizer’s medical devices and combination products, including design control activities, investigational clinical studies through to commercial product applications. These activities could bridge across both large and small molecule projects and the device strategist will work with the CMC product lead of the programs to support the device requirements. The Reg-CMC Medical Device strategist will develop and document regulatory strategies for CMC submissions specific to Devices and will work with other WRS colleagues on global regulatory strategies, including contributing to the development and execution of regulatory interactions. The GCMC medical device strategist will represent GCMC on project/asset teams and serve as a technical and scientific resource on regulatory CMC topics to identify regulatory / technical issues and to help develop solutions, contingency plans and to interpret relevant global regulations and guidelines for specific project issues. The individual will also participate in internal initiatives to develop GCMC infrastructure and processes.

Responsibilities

• Interpreting regulatory requirements, developing strategies, assessing risks and developing contingencies.
• Preparation of correspondence and applications to global regulatory agencies
• Helping to define submission strategies and contents
• Act as Regulatory CMC representative in formal meetings and teleconferences with regulatory authorities
• Leading the preparation of device-related CMC information for submission to global regulatory agencies
• Supporting overall CMC strategies, assesses risks and develops contingency plans as a member of cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
• Representing GCMC on due diligence teams and
• Representing Pfizer on CMC focused industry initiatives

Qualifications

The ideal candidate:

• Has solid experience with regulatory submissions for pharmaceutical, biological, and device combination products
• Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
• Is willing to learn and expand expertise to new product areas and markets
• Operates independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams.
• Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
• Creates / contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pfizer portfolio.
• Collaborates effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and support the compliance of Pfizer products
• Manages the resolution of regulatory CMC/information issues with project/program stakeholders.

EDUCATION AND EXPERIENCE

Bachelors degree in a scientific area and 10+ years of relevant experience

Must have a broad functional knowledge of pharmaceutical sciences or medical device development.

Candidate should demonstrate:

• Leadership skills, influencing and persuading skills
• Excellent cross-cultural awareness and understanding
• Strategic thinking and decision making
• Team collaboration
• Excellent planning, organizational and project management skills
• Excellent communication, interpersonal and relationship building skills
• Experience in medical device development and registration is desired but not required.

TECHNICAL SKILLS REQUIREMENTS

Technical and scientific understanding of drug development with technical writing skills. May serve as Subject Matter Expert in medical device or combination products and be recognized as a regulatory CMC resource for expertise in device-related regulatory issues

Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.

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