Global Regulatory Affairs CMC Manager

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Regulatory CMC Biologics Manager

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. 

Role Summary

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

• 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.

QUALIFICATIONS

Education & Experience:

• Bachelor’s degree plus 5 years experience or
• Master's degree plus 3 years experience
• preferred in a pharmaceutical(Biology, Chemistry, Pharmacy or related science) &/or technical discipline
• with 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 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 division. 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.

PHYSICAL/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

• 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.
• Eligible for Employee Referral Bonus: YES
• This job is a US/PR Exempt Grade: 011
• US/PR colleagues who are issued an Incident Final Warning (IFW) disciplinary action are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.  
• US/PR colleagues who are on an active Performance Improvement Plan (PIP) are not eligible to post and compete for a position for the duration of the Performance Improvement Plan (PIP).  

Other Job Details:

    
Last Date to Apply for Job: 11/02/2021
    Additional Location Information: USA - MA - Andover; IRL - Dublin, Grange Castle; United Kingdom - Walton Oaks; United States - Illinois - Lake Forest; United States - New York - Pearl River; United States - Michigan - Kalamazoo; United States - Connecticut - Groton
    NO Relocation Package 
    Eligible for Employee Referral Bonus 

   

#LI-PFE

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.

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 non-discrimination 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.

• Global Job Level: J070 - Grade: 011 (US)

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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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