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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