PFIZER
Executive/Senior Executive, Regulatory Affairs CMC, Bachelor’s / Master’s
degree in pharmaceutical sciences &/or technical discipline
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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