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Director, Regulatory Affairs-Brands CMC

at Pfizer, Inc in Bentonville, Arkansas, United States

Job Description

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.

Guide the Co-Development teams in developing complex CMC strategies for Phase 1 through 3 clinical submission and initial commercial registration, including risk mitigation.

Develop ideas and lead/co-lead projects across division and develop and manage plans to exceed objectives.

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.

Execute training related activities {e.g. compliance-related, HR policies) and 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.

Able to lead complex projects or team initiatives to support short-term operational goals 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

BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.

A minimum of 10 - 15 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.

A minimum of 5 years drug substance or drug product development or manufacturing technical support experience.

In-depth 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.

In-depth knowledge and strong 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)

An advanced understanding and in-depth 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... For full info follow application link.

 

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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Job Posting: 3106715

Posted On: Oct 27, 2021

Updated On: Nov 13, 2021