PFIZER Hiring Executive/Senior Executive,
Regulatory Affairs CMC Bachelor’s / Master’s degree in pharmaceutical sciences
India - Chennai
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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