Regulatory lead

ROLE SUMMARY

The Scientist (R3) Regulatory Submission Lead is responsible for scientific writing and quality control for the Pharmacokinetics, Dynamics, and Metabolism (PDM) and Nonclinical Pharmacology (NCP) components in regulatory submissions. The colleague will represent PDM and NCP in crossline meetings, create and maintain submission and study templates, and guide teams on study inclusion in regulatory filings. The colleague will ensure documentation compliance with regulatory requirements and Pfizer Global Style Guidelines, liaise with global colleagues, and drive continuous improvement in document submission processes. The colleague will also support in/out-licensing coordination, data transfers, and participate in audits and post-audit improvements.

ROLE RESPONSIBILITIES

We are seeking a highly motivated Regulatory Submission Lead to join our team. Primary responsibilities include scientific writing and quality control of regulatory documents. Effective performance on large teams and comfort in a large, matrixed organization is essential. As a Scientist, the successful candidate will be expected to author submission components and collaborate with team members and partner lines to advance a program through regulatory milestones. The successful candidate will demonstrate a capacity to learn fast, think critically, collaborate and communicate efficiently in a team environment.

• Prepare the PDM or NCP sections of submission documents working in partnership with the PDM project representatives or RU leads.
• Conduct QC review of documents included in regulatory submissions.
• Represent PDM / NCP on crossline regulatory document review meetings. Respond and integrate team review comments. Prepare query response in conjunction with project representative.
• Partner with RU’s, PDM, DSRD, Clinical, Regulatory, and Safety Risk Management to ensure PDM document content remains fit for purpose, create guidance’s and work toward efficiency gains and well-defined processes.
• Liaise with other submission writers to ensure consistency in document preparation with a fit for purpose approach and ensure the creation and maintenance of standard templates for regulatory submission components.
• Participate in efforts related to utilization, maintenance, and improvement of tools and document systems (e.g. AI or automation) used in regulatory submissions.
• Promote quality as a best practice within PDM or Research Units based on knowledge of regulatory requirements, departmental guidelines and QC experience.
  
  

QUALIFICATIONS

Must Have

• BS 6 to 8 years of experience or MS with 4 to 6 years of experience in chemistry, biochemistry, biology, or related scientific discipline.
• Knowledge of the relevance and impact of ADME and/or pharmacology studies in drug discovery and development.
• Established history of working efficiently in a team environment and collaborating with other colleagues to complement individual areas of expertise.
• Strong communication, scientific writing, and presentation skills.
• Ability to manage multiple projects simultaneously
  
  

QUALIFICATIONS

Nice to Have

• Experience within the pharmaceutical or biotechnology industry involved in drug discovery and development.
• Knowledge of global regulatory requirements, relevant ICH guidelines, and country-specific filing requirements.
• Ability to analyze, devise and implement scientific writing improvements/solutions to address business needs.
• Ability to lead initiatives and work in a highly matrixed environment.
• Willingness to learn, ability to adapt quickly, and apply new techniques.
  
  

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $77,100.00 to $128,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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.

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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.

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Research and Development