Pfizer

Regulatory Manager, GCMC Vaccines

Employer
Pfizer
Location
Sanford, North Carolina
Salary
Competitive
Posted
September 13 2021
Ref
4824333
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

JOB SUMMARY
  • Collaborates with departmental and cross-functional colleagues (e.g., G-CMC, GRA, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.
  • Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.
  • Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
  • Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.
  • Leveraging both technical & regulatory knowledge, to mitigate risks.
  • Delivery of high quality regulatory submissions.
  • Execution of regulatory policies and operational processes.
  • Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
  • Execution and implementation of policies and operational processes.


JOB RESPONSIBILITIES
  • Develop effective relationships with local & global internal partners, i.e., R&D (PTx, BTx, PCH), PGS, GRA, BU's, etc.
  • Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • 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.
  • Serve 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.
  • Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
    • Mentoring colleagues may be expected within focus area of expertise.
  • Manage colleagues within a GCMC function, only if the position requires supervision of personnel.
    • managing a small group of colleagues within a GCMC function, conduct performance-management & training related activities, encourage & support a healthy work/life balance, support roll-out of HR policies, assist recruitment & hiring vacancies, provide guidance & facilitate opportunities for individual development, encourage colleague participation in cross-disciplinary forums & learning opportunities, engage colleagues in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
    • Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.
    • Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
    • fostering & actively developing GCMC talent
  • Develop relationships with regulatory authorities to improve Pfizer's regulatory success
  • May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.
  • Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.


QUALIFICATIONS / SKILLS

Education :
  • Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.

Experience :
  • 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.
    • Experience operating within GMP, GLP, or GCP related SOPs.
    • Product release system exposure helpful
  • Managing colleagues within a GCMC function, only if the position requires supervision of personnel.
    • 2+ years' management & supervisory experience with technical project and/or staff.
  • Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.
    • Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
    • Strong understanding of CMC change management processes and CMC CTD content/structure.
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
    • Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools
  • Prior experience managing projects is preferred.
    • Lean and/or SixSigma experience helpful.


TECHNICAL SKILL REQUIREMENTS:

Technical and/or other job-related skills
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
  • Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
    • Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
    • Strong understanding of CMC change management processes and CMC CTD content/structure.
    • Understanding of identifying and mitigating compliance risks through proper management of CMC product content
  • Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP's required to assess technical, scientific & regulatory merits ofCMC information, commitments and data to lead teams and/or project(s).
    • Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
  • An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.
    • Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.
    • 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.
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
    • Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools.
  • Experience engaging in the external regulatory & pharmaceutical environment is preferred.
  • Prior experience managing projects is preferred.
    • Lean and/or SixSigma experience helpful.


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.

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