Pfizer – Openings for Freshers & Experienced Trainee Executive – Regulatory Affairs || Apply Now
The Trainee 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 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.
Education and Experience:
- Bachelor’s / Master’s degree in pharmaceutical sciences &/or technical discipline with 0-1 years of relevant experience in the pharmaceutical industry
- Advanced skills in written & oral communications are mandatory.
- Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
Technical and/or other job-related skills:
- 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.
- Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
- Emerging awareness of new scientific or manufacturing technology