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GCMC Regulatory Manager


Madison, NJ
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Job Details

Job Title GCMC Regulatory Manager

JobID 1048942-1852

Location: Madison, NJ

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

The GCMC Manager is responsible for the development of regulatory strategies, submissions and compliance activities for medical device-related development programs and commercial products supporting Pfizer's Consumer Health Business Unit. The manager will: *Generate and drive strategic and operational global regulatory CMC direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. *Lead the preparation of medical device information for submission to global regulatory agencies, assess risks and develop contingency/mitigation plans. *Serve as the medical device regulatory lead and contribute to due diligence teams exploring new business opportunities.*Act as the global medical device regulatory CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic decisions. *Manage delivery of regulatory and strategic activities for assigned medical device programs, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio. *Represent CMC during interactions with regulatory agencies and external partners.The GCMC Manager is accountable for:*Ensuring regulatory conformance & consistency globally in compliance with external regulatory requirements & internal quality procedures.*Demonstrating global regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen , i.e., regulatory strategy development, regulatory submission quality, investigations, review & approval of policy & quality standards*Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks. *Delivery of high quality regulatory submissions & submission management plans. *Execution of regulatory policies and implementation of policies and operational processes for delivering the product portfolio.


The GCMC Manager is responsible for:*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*Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures. *Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.*Prioritizing assigned workload appropriately. *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.*Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, provideingconsultation as a scientific/technical resource for assigned projects, and sharing experience with colleagues.


Education & Experience:*Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 3 years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3 years pharmaceutical or regulatory experience.*Minimum of 2 years of hands-on CMC or device submission 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.Technical and/or other job-related skills:*Sufficient level of knowledge in development & commercial activities and cGMP's is required to assess technical, scientific & regulatory merits of CMC information and data to lead teams and/or project(s). *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.*Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.*Experience engaging in the external regulatory & pharmaceutical environment is preferred.Possesses sound understanding of business expectations across divisionsPHYSICAL/MENTAL 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.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS *The GCMC Manager is a role expected to travel domestically & internationally as required.*The external global regulatory environment is dynamic & may demand work outside of conventional working hours and on weekends from time to time.

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*GCMC Regulatory Manager*
*Madison, New Jersey*

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