Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and the 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.

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group

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:

Click Here to Apply Now

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

Click for More Regulatory Affairs Jobs


Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group

LEAVE A REPLY

Please enter your comment!
Please enter your name here