Manager – Regulatory Affairs CMC, Upjohn

Manager – Regulatory Affairs CMC, Upjohn

Pfizer Asia Pacific Pte Ltd
Chennai India
Not Specified
Not Specified

Job Description


Job Description :
Why Patients Need You
The ever-changing regulatory environment makes it necessary that Upjohn Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.What You Will Achieve
You will represent Upjohn Pfizer as CMC Author/Strategist in the regulatory affairs team. Your understanding of regulatory procedures will help in development of submission of product registration, changes, variations, supplements, amendments and periodic annual reports.
As a member, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. How You Will Achieve It
Role Responsibilities

  • 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.

  • Authors and/or compiles CMC submission packages globallyincludingM3/M2 CTD sections,country specific dossiers, supplements / variations for Lifecycle Management (LCM) submissions and ensure effective data presentation and quality, in collaboration with GRS CMC as per agreed timelines.

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

  • Reviews and applies pertinent global regulatory guidelines

  • Develops technical justification of change for an agency submission

  • Updates M3/M2 dossier and Coordinates M3.2.R Ancillary documents

  • Presenting and articulating issues for resolution, communicating regularly with GRS-CMC to ensure alignment and Flags identified risks

  • Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.

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

  • Developing effective relationships with local & global internal partners, i.e., R&D, UGS, Country Regulatory Leads, other CMC lines

  • Maintains conformance systems maintenance in support of the GRS CMC

QualificationsMust-Have

  • Masters/Bachelor's Degree in Pharmacy or equivalent

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

  • Advanced skills in written & oral communications are mandatory.

  • Knowledge of the regulations and guidelines in the various markets

  • Computer literacy and ability to learn new systems

  • Ability to work well cross functionally and to develop productive/collaborative relationships

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.
Non-Standard Work Schedule, Travel and Environmental
  • Owing to the global nature of the position, occasional work outside of conventional working hours may be needed.

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

Job Details

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Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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