Pfizer Recruitment June 2020 Bachelor’s / Master’s degree in pharmaceutical sciences &/or technical discipline for Assistant Manager – Regulatory Affairs @ India – Chennai. Interested candidates Apply online for selection as detailed below.
Vacancy details:
- Post Name: Assistant Manager – Regulatory Affairs
- Qualification: Bachelor’s / Master’s degree in pharmaceutical sciences &/or technical discipline
- Experience: Minimum of 5+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
- Location: India – Chennai
- Salary :NA
- Openings :NA
Job Description: We have requirement for the post of Assistant Manager – Regulatory Affairs in Pfizer !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 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 quality review of regulatory CMC submissions.
- Serving as a technical and scientific resource and providing guidance for 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.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and apply online