Regulatory Affairs Manager CMC

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 regulatory lifecycle (development and post-approval). 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 able to support negotiations with regulatory authority personnel to expedite approval of pending registrations and respond to queries.
  
• As a Manager, you will provide guidance to cross-functional teams for managing projects. Your ability to develop and manage plans will help in preparing submission strategies and providing areas of improvement for products and processes. Through your comprehensive knowledge of principles and concepts in Regulatory Affairs CMC and foundational knowledge of other disciplines you will contribute towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate alignment between different teams on regulatory strategies.
  
• It is your hard work and focus 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 and Global Brands CMC portfolio, including Anti-Infectives, providing initial regulatory assessments and developing regulatory strategies with appropriate supervision.
  
• Act as the global CMC representative, or supports the global CMC representative, within cross-functional project teams, including Pharmaceutical Sciences, Manufacturing, and Co-Development teams. Accountable for multiple assigned projects and activities, completing work within assigned product portfolio, and working with group/project teams, all with appropriate supervision.
  
• Interpret CMC regulatory requirements for human health prescription products, develops initial strategies, assess risks, and develops contingency proposals with appropriate supervision. Uses technical and scientific knowledge to conduct the initial analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
  
• 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.
  
• Ability to collaborate effectively across a network of other stakeholders, partners, and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer essential pharma therapeutic portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders.
  
• Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with global Chemistry Manufacturing and Controls principles of integrity.
  
• Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.
  

Qualifications

Must-Have

• BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
  
• A minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
  
• Minimum of 2-3 years drug substance or drug product development or manufacturing technical support experience.
  
• Experience with diverse dosage forms is desirable.
  
• 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.
  
• Candidate is required to have a robust understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of 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.
  
• Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems)
  
• A clear track record of effective teamwork, collaboration, and communication, and demonstrated leadership ability in a cross-functional matrix team environment.
  
• Project management along with planning/organizing by prioritizing and planning work activities and change agility.
  

Nice-to-Have

• Experience in CMC supporting clinical and post approval programs with diverse dosage forms is desirable.
  

*Last date to apply is February 15, 2023*

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The annual base salary for this position ranges from $96,900.00 to $155,400.00. In addition, this position offers an annual bonus with a target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

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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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