Pfizer - Openings for Freshers & Experienced Trainee Executive - Regulatory Affairs

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 

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