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

Pfizerites are united by the knowledge that what they do really makes a difference in society — that they help people live longer, healthier, happier and more productive lives.

The global Pfizer leadership is making efforts to make the company lean and agile. Employees are encouraged to be innovative and entrepreneurial. We are also working to create an environment where all colleagues have the opportunity to grow and maximize their contributions to the company’s success.

Pfizer is a Fortune 500 company that embraces the spirit of a small company while exploiting the advantages of its unmatched scale and reach.

Position: Senior Executive, Regulatory Affairs CMC, Upjohn

Location: Chennai, Tamil Nadu

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

Salary: Negotiable

Contact Details:

Click Here to Apply Now

Click for More Regulatory Affair 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