Pfizer GCMC Manager in Groton, Connecticut
The GCMC Manager possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works within a GCMC function.
The GCMC Manager is accountable for:
Ensuring regulatory conformance & consistency globally in compliance with external regulatory requirements & internal quality procedures.
demonstrating regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen , i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy & quality standards
Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.
Preparation & Delivery of high quality CMC regulatory submissions & submission management plans for global regulatory agencies.
Execution of regulatory policies and implementation of policies and operational processes for delivering the product portfolio.
The GCMC Manager is responsible to/for:
Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.
Authors and/or coordinates NCE, post approval, renewal and line extensions to meet filing requirements for regulatory CMC submissions. Coordinates & contributes to responses to Agency queries and performs quality review of regulatory CMC submissions.
Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
Prioritize & independently complete assigned workload appropriately.
developing effective relationships with local & global internal partners, i.e., R&D (PTx, BTx, PCH), PGS, WSR, BU's, etc.,
Developing relationships with regulatory authorities to improve Pfizer's regulatory success
Execute training related activities (e.g. compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
Manage and contribute to GCMC projects, initiatives & actions.
May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.
Mentoring colleagues may be expected within focus area of expertise.
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 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.
Experience engaging in the external regulatory & pharmaceutical environment is preferred.
Emerging awareness of new scientific or manufacturing technology.
Possesses sound understanding of business expectations across divisions
May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains
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.
May participate in Due Diligence exercises with supervision.
Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline
6-8 years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) with BS degree
3-6 years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) with MS degree or PhD
Advanced skills in written & oral communications are mandatory.
3+ years pharmaceutical regulatory experience.
Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
Prior experience managing projects is preferred.
- 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is expected to travel domestically & internationally as required.
The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.
Other Job Details:
Eligible for Employee Referral Bonus: Yes
Additional Location Information: Groton - CT, Kalamazoo, MI, Peapack, NJ or Collegeville, PA
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EEO & Employment Eligibility
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