Sr. Manager, Regulatory CMC

About Pfizer
A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
Regulatory CMC Sr. Manager is responsible for the development and execution of complex 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. Acts as 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. Acts 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. Represents Regulatory CMC on due diligence teams and representing Pfizer on CMC focused pharmaceutical industry initiatives.
Responsibilities
Serves as a GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies with a focus on combination products. Acts as 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 including for combination products. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Responsible for the development of CMC documentation for combination products, 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.
Qualifications
Scientific degree in a relevant subject (PhD preferred, science related BSc or MSc required) An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (with 7+ years experience in a relevant area). Proven ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects. Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals. Experience of regulatory agency interactions is required. Technical and scientific understanding of biopharmaceutical drug development with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains. 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. PHYSICAL/MENTAL REQUIREMENTS General office based activities, requiring the operation of telephone and computer systems. Occasional business travel is required.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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