Job Description

ROLE SUMMARY

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.

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. We value every employee and throughout their career encourage them to grow, develop and express their views freely.

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.

ROLE RESPONSIBILITIES

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, BUs, etc.,
* Developing relationships with regulatory authorities to improve Pfizers 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.

QUALIFICATIONS

Education & Experience:

* Bachelors degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 6+ 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 and solid understanding of the development & commercial activities and cGMPs 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.

Desired Competencies:

* Decision Making
* Acts Decisively
* Applies experience & operates independently to resolve complex issues.
* Risk Management
* Ability to recognize and address risks across projects and programs.
* Manages regulatory risks & ambiguous situations under limited supervision.
* Innovation/ Creativity
* Investigates novel and unconventional approaches to address issues and solve problems.
* Scientific & Regulatory Leadership
* Ability to develop and/or lead projects or team initiatives to support short-term operational goals.
* Ability to think globally across zones and divisions.
* Ability to influence at the work group/discipline project team level.
* Teamwork/ Collaboration
* Ability to build effective teams & lead change.
* Communication
* Communication & Negotiation skills

Other Job Details:

* Last Date to Apply for Job: February 12, 2021
* Eligible for Employee Referral Bonus: YES

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Sunshine Act

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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.

Regulatory Affairs

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