Regulatory CMC Manager / Senior Manager
Pfizer Inc - Andover, MA
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Org Marketing Statement
Pfizer Inc: Working together for a healthier world
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Regulatory CMC manager / Senior Manager is responsible for the development of CMC regulatory strategies, submissions and compliance activities for biopharmaceutical development programs and commercial products.
Supports / leads the preparation of CMC information for submission to global regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans.
May act as the Global CMC representative or contribute support to the Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products.
Depending on experience, may operate 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 biopharmaceutical portfolio at large. Leads document management and information management teams, within Global CMC / groups outside Global CMC.
Serves as a GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.
Acts as the Global CMC representative, or contributes support to the Global CMC representative, within cross-functional project teams. Accountable for assigned projects and activities, independently completing work within assigned work group/project teams, for multiple projects.
Interprets CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer biopharmaceutical portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders.
Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.
EDUCATION AND EXPERIENCE
Scientific degree in a relevant subject.