Manager, Regulatory CMC Strategy, Anti-Infective Portfolio

Collegeville, Pennsylvania; Kalamazoo, Michigan
February 17 2021
Position Type
Full Time
Organization Type
Job Type

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 PBG Hospital Business Unit Brands portfolio with appropriate supervision.


Provide strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering development, initial registrations and approval/post approval activities. Leads the initial preparation of CMC information for submission to global regulatory agencies, 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 initial interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions with appropriate supervision.

Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including initial development, post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.

Operate with appropriate supervision to resolve issues and manage regulatory risks and ambiguous situations within project teams.

Serve as a CMC strategist and project leader for projects within the global Brands portfolio, providing initial regulatory assessments and developing regulatory strategies with appropriate supervision.

Act as the global CMC representative, or contributes support to the global CMC representative, within cross-functional project teams, including Pharmaceutical Sciences and Co-Development teams. Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with supervision.

Interpret CMC regulatory requirements for human health prescription products, develops initial strategies, assess risks and develops contingency proposals with appropriate supervision. Uses technical and scientific knowledge to conduct the initial 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 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 essential pharmatherapeutic portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions with appropriate input from leadership, exhibits sound and accurate judgment and makes timely decisions.

Ability 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.

  • BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
  • Must have a minimum of 3 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
  • Must have a minimum of 2-3 years drug substance or drug product development or manufacturing technical support experience. Experience with diverse dosage forms is desirable.
  • A 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 robust understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical 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 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.


Normal office based and needs to be able to travel on public transport, including international.


Occasional business travel.

Other Job Details

Additional Posting Locations: United States - Michigan - Kalamazoo; United States - Pennsylvania - Collegeville

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