Global Regulatory Affairs CMC Lead
Sanofi
Regulatory Submission Lead
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Groton • Connecticut, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $77,100 - $128,500 per year
Job Level
Senior
About the role
- Responsible for scientific writing and quality control for the Pharmacokinetics, Dynamics, and Metabolism (PDM) and Nonclinical Pharmacology (NCP) components in regulatory submissions.
- Represent PDM and NCP in crossline meetings.
- Create and maintain submission and study templates.
- Guide teams on study inclusion in regulatory filings.
- Ensure documentation compliance with regulatory requirements and Pfizer Global Style Guidelines.
- Liaise with global colleagues and drive continuous improvement in document submission processes.
- Support in/out-licensing coordination, data transfers, participate in audits and post-audit improvements.
Requirements
- 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.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
scientific writingquality controlregulatory submissionssubmission templatesdocumentation compliancedata transfersauditspharmacokineticspharmacodynamicsmetabolism
Soft skills
communicationcollaborationteamworkproject managementpresentation skillsguidancecontinuous improvement
