5 days old

Manager Regulatory Affairs CMC, Upjohn

The Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.

+ Execution of CMC strategies for product Supply initiated prioritized post approval changes globally in collaboration with the GRS-CMC.

+ Global regulatory strategy development in collaboration with the GRS-CMC.

+ Liaise with Upjohn/Pfizer Global Supply and other support functions as needed.

+ Use of regulatory systems and management of CMC documentation and information in support of the GRS-CMC.

**The Manager, Regulatory Affairs CMC, Upjohn is responsible for:**

+ Manages the day to day work activities of the self and Provides guidance to the team for moderately complex projects

+ Act as SME and mentor to provide review support and guidance to the team as necessary.

+ Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC

+ Authors and/or compiles CMC submission packages globally, in collaboration with GRS CMC as per agreed timelines.

+ Reviews technical/supportive information for submission to support change

+ Reviews and applies pertinent global regulatory guidelines

+ Develops technical justification of change for agency submission

+ Updates M3 dossier

+ Coordinates M3.2.R Ancillary documents

+ Flags identified risks to the GRS CMC and/or appropriate leadership

+ Represents CMC TEAM and meets with key stakeholders to resolve challenges as necessary.

+ Coordinates internal document review and sign off.

+ Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.

+ Supports Query and/or commitment management in collaboration with GRS CMC

+ Maintains conformance systems maintenance in support of the GRS CMC

**Education and Experience:**

+ Master's degree in pharmaceutical sciences &/or technical discipline with 12-15 years of relevant experience in the pharmaceutical industry and at least 10+ years pharmaceutical regulatory experience.

+ Minimum of 8+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

+ Advanced skills in written & oral communications are mandatory.

+ Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

**Technical and/or other job-related skills:**

+ Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP's required to assess technical, scientific & regulatory merits of CMC information, commitments and data.

+ Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.

+ An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.

+ Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.

+ Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

+ Experience engaging in the external regulatory & pharmaceutical environment is preferred.

+ Emerging awareness of new scientific or manufacturing technology.

+ Possesses sound understanding of business expectations across divisions

+ May serve as Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

+ Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs


Posted: 2020-10-14 Expires: 2020-11-13

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Manager Regulatory Affairs CMC, Upjohn


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