Description : Pfizer Offers Manager Regulatory CMC Job Position For Interested Candidate, Any One Can Apply Through Official Website For This Job.
Job Type : Manager
Organisation Type : Pharma
Work Type : Full Time
Employer : Pfizer
Job Location : United States – Connecticut – Groton
United States – Pennsylvania – Collegeville
United States – New Jersey – Peapack
Salary : Based On Work or Expertise
Start Date : Apply Start
Last Day : 14 May 2022
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Education & Experience :
- Bachelor’s degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 5+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D)
- Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
- Advanced skills in written & oral communications are mandatory.
- Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
- Prior experience managing projects is preferred
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 to lead teams and/or project(s).
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 & experience of interactions with regulatory authorities for projects.
Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.
May participate in limited interactions with regulatory authorities to respond to direct requests, e.g., response to provide method validation package information, registration samples, etc., either directly or in conjunction with Regulatory Affairs.
Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
Emerging awareness of new scientific or manufacturing technology.
Possesses sound understanding of business expectations across divisions Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing discipline and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
Physical Requirements : This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.