HomeRegulatory AffairsAssistant Manager | Regulatory Affairs | Pfizer India | Chennai

Assistant Manager | Regulatory Affairs | Pfizer India | Chennai


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Position: Assistant Manager of Regulatory Affairs

Location: Chennai, Tamilnadu

Job Description:

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

  • Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Prioritizing & independently completing assigned workload appropriately with minimal supervision.
  • Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing the experience with colleagues and help peer review the variations as required.
  • Authoring and/or coordinating CMC activities for new registrations, post-approval changes, renewals, annual reports, and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing the quality review of regulatory CMC submissions.
  • Serving as a technical and scientific resource and providing guidance for the completion of difficult and complex projects.
  • Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.

Technical and/or other job-related skills:

  • Sufficient level of knowledge and a 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 the 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 interpret and apply 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 a 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 expertise in specific regulatory domains
  • Demonstrates sound understanding and advanced knowledge of the principles, practices, and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts, and operations in other relevant disciplines.

Qualification: B.Pharma/M.Pharma or Any other Equivalent technical Qualification

Experience: 6-10 Years out of which 5 Years in Pharmaceutical Regulatory Experience

Salary: Negotiable

Contact Details:

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

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