Pfizer Recruitment August 2020. 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.
Important Vacancy details:
- Post Name: Executive/Senior Executive, Regulatory Affairs CMC
- Education:Bachelor’s / Master’s degree
- Experienced:3 to 6 years
- Location: India – Chennai
- Salary: NA
- Openings :NA
Job Description: We have requirement for the post of Executive/Senior Executive, Regulatory Affairs CMC in Pfizer !
- 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 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 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.
- Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online