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Executive/Sr Executive | Regulatory Affairs CMC | Pfizer – UpJohn | Chennai, TN


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Position: Senior Executive, Regulatory Affairs CMC, Upjohn

Location: Chennai, Tamil Nadu, India

Job Description:

The Executive/Senior Executive, Regulatory Affairs CMC, Upjohn is responsible for:

  • Serving as CMC representative on assigned core project(s), and help GRS-CMC in managing project activities, help develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Help GRS-CMC complete the task by Prioritizing & completing assigned workload appropriately under minimum supervision.
  • Presenting and articulating issues for resolution, communicating regularly with GRS-CMC to ensure alignment
  • 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.
  • 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.
  • 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.
  • Emerging awareness of new scientific or manufacturing technology
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

Qualification: B.Pharma/M.Pharma or Relevant

Experience: 3-6 Years of relevant experience in the pharmaceutical industry

Salary: Negotiable

Contact Details:

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