Pfizer

Regulatory Affairs Senior Manager CMC

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
October 13 2021
Ref
4828007
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, managing regulatory documents, etc. You will also be negotiating with regulatory authority personnel to expedite approval of pending registrations and respond to queries.
  • As a Senior Manager, your advanced knowledge of the principles and concepts in regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead projects across the division. While managing project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvements.
  • It is your leadership skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Serve as a CMC strategist and project leader for projects within the Global Pfizer Biopharmaceuticals Group Hospital Category portfolio, including Anti-Infectives, providing regulatory assessments and developing regulatory strategies independently or with minimal supervision.
  • Guide the Co-Development teams in developing CMC strategies for Phase 1 through 3 clinical submission and initial commercial registration with minimal supervision.
  • Develop ideas and lead/co-lead projects across division and develop and manage plans to achieve objectives with minimal supervision.
  • Responsible for the authoring of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
  • Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.
  • Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  • Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply, Worldwide Strategy and Regulatory, Commercial Business Units, etc.
  • Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assesses risks, and develops contingency plans, including major, complex applications with minimal supervision.
  • Participate in cross-disciplinary forums & learning opportunities.
  • Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with global Chemistry Manufacturing and Controls principles of integrity.
  • Displays a willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions with minimal supervision.
  • Able to develop and/or lead projects or team initiatives to support short-term operational goals with minimal supervision and contribute to the development of global regulatory initiatives.
  • Candidate demonstrates a breadth of diverse experiences and capabilities including the ability to influence and collaborate with peers.

Basic Qualifications

Must-Have
  • Bachelor's Degree plus 9 years experience or
  • Master's Degree plus 7 years experience or
  • PhD or equivalent scientific/engineering/pharmaceutical development sciences degree plus 4 years experience
  • Relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
  • A minimum of 3 years drug substance or drug product development or manufacturing technical support experience.
  • Demonstrated regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.
  • Strong knowledge and solid understanding of the development and commercial activities, and (Current) Good Manufacturing Practices (part of GxP) required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead project(s)
  • A sound understanding and advanced functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of biologics pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
  • Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
  • Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
  • A clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment.
  • Product management skills along with planning/organizing by prioritizing and planning work activities and change agility.
  • Adaptability and self-motivation, able to prioritize effectively with strong problem solving and planning abilities.

Nice-to-Have
  • Experience in CMC supporting clinical and post approval programs with diverse dosage forms, particularly sterile products, is desirable.


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS
  • Normal office based and needs to be able to travel on public transport, including international.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Travel to external (trade association or agency) or internal meetings as required.

Other Job Details:

Last Date to Apply for Job:10/26/2021
Additional Location Information:Ireland - Kildare - Newbridge; USA - CT - Groton; United States - Michigan - Kalamazoo; United States - New Jersey - Peapack
NO Relocation Package
Eligible for Employee Referral Bonus

#LI-PFE

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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