Job Description

ROLE SUMMARY Experienced CMC professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting the Pfizer Biopharmaceuticals Group with minimal supervision. Provide and drive strategic and operational CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities, within the Asia Pacific (APAC) or Africa & Middle East (AfME) or European Union (EU) markets. Leads the initial preparation of CMC information for submission to regulatory agencies within the region, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans with supervision. Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of regional implications for strategic CMC decisions with minimal supervision. Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio. May represent CMC during interactions with regulatory agencies and external partners either directly or in conjunction with others within Global Regulatory Affairs. Operate with minimal supervision to resolve issues and manage regulatory risks and ambiguous situations within project teams. Initial investigation of opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems with supervision. ROLE RESPONSIBILITIES Serve as a CMC strategist and project leader for projects within the Pfizer Biopharmaceuticals portfolio regionally registered and marketed in APAC or AfME or EU, providing regulatory assessments and developing regulatory strategies with minimal supervision. Act as the CMC representative, or contributes support to the CMC representative, within cross-functional project teams for products managed regionally. Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with minimal supervision. Interpret CMC regulatory requirements for human health prescription products, develops strategies, assess risks and develops contingency proposals with minimal supervision. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness. Responsible for the authoring of CMC documentation, coordination and management of submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control. Makes decisions that may require developing new options to resolve moderately complex problems. Also makes decisions guided by policies in non-standard situations. Able to operate independently in ambiguous situations and makes decisions within guidelines and policies. 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 essential pharmatherapeutic portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions. 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 with minimal supervision. QUALIFICATIONS Postgraduate in Pharmacy or equivalent Sciences degree. Must have a minimum of 8 - 10 years regulatory experience in new registrations / post approval changes. Experience with diverse dosage forms, particularly sterile products / Solid Orals, is desirable. An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain. Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio. Candidate is required to have a sound understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding ofpharmaceutical drug development with technical writing skills. 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. The candidate is required to have a clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment. Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes. Work Location Assignment:Flexible Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE

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