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Regulatory Affairs Senior Manager CMC

Employer
Pfizer
Location
Groton, CT
Start date
Sep 29, 2022

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Job Details

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 Senior Manager, your advanced knowledge of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex 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
  • Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives.
  • 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 Business Units, etc.
  • Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Essential Health portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision.
  • 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 individual development plans, 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.
  • Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.

Qualifications

Must-Have
  • Bachelor's Degree
  • 7+ years of experience
  • Drug substance or drug product development or manufacturing technical support experience
  • Experience in regulatory Chemistry Manufacturing and Control (CMC) or with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain
  • Good level of 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 teams and/or project(s)
  • Ability to learn and navigate tracking/change control systems, and willingness to train and support others in system use
  • Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
  • Strong interpersonal and leadership skills
  • Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems

Nice-to-Have
  • Master's degree
  • Relevant pharmaceutical experience
  • Experience managing projects
  • Experience with diverse dosage forms, particularly sterile products


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.


#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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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