Pfizer-posted 2 months ago
$77,100 - $128,500/Yr
Full-time • Mid Level
Groton, CT
Chemical Manufacturing

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.

  • 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.
  • 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 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.
  • BS with 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.
  • 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.
  • 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.
  • Health benefits to include medical, prescription drug, dental and vision coverage.
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