Pfizer careers Hiring Executive/Senior Executive, Regulatory Affairs CMC Bachelor’s / Master’s degree in pharmaceutical sciences Apply Now
The Executive/Senior 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 3-6 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:
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.
Demonstrated commitment &
dedication to scientific & regulatory integrity & quality compliance.
Emerging awareness of new scientific or manufacturing technology
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