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GCMC Manager


Groton, CT
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Job Details

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 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.

+ May serve externally as a representative to pharmaceutical trade group advisory committees.

+ Execute performance-management & training related activities ( e.g . 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.

+ Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

+ Manage and contribute to GCMC projects, initiatives & actions.

+ Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

+ Prioritize 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.

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 regulatory experience.

+ 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. 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, 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.

+ Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

+ Experience engaging in the external regulatory & pharmaceutical environment is preferred.

**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.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Other Job Details:**

+ **Last Date to Apply for Job: 12/14/17** Additional Location Information: Peapack, NJ Collegeville, PA Kalamazoo, MI Pearl River, NY New Bridge, Ireland Grange Castle, Ireland Sandwich, UK

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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