Manager, Regulatory CMC Strategy

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.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for large molecules and antibody-drug conjugates 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.

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.

How You Will Achieve It

• Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the Department.
  
• Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with minimal supervision.
  
• Responsible for the development 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.
  
• Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions along with prioritizing assigned workload appropriately.
  
• Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  
• Develop effective relationships with local and global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
  
• Leverage both technical and regulatory knowledge, to mitigate risks.
  
• Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
  
• Use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
  

Qualifications

Must-Have

• Bachelor's Degree or equivalent/graduate degree
  
• 5+ years of pharmaceutical industry experience
  
• 3+ years of regulatory experience
  
• Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience
  
• Demonstrated commitment to scientific and regulatory integrity, quality compliance
  
• Excellent planning, organizational and project management skills
  
• Advanced skills in written and verbal communications
  
• Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems
  

Nice-to-Have

• Technical discipline with 6+ years of experience in the pharmaceutical industry technical experience
  
• Minimum of 2+ years hands-on CMC authoring experience (initial registrations or post-approval)
  
• Minimum of 2+ years management/supervisory experience
  
• Experience in R&D, Quality, Technical, Operations, Manufacturing
  
• Experience operating within GMP, GLP, or GCP
  

Other Job Details:

• Work Location Assignment:Flexible
  
• Last date to apply: April 3, 2024
  

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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. This position requires permanent work authorization in the United States.

Regulatory Affairs