Senior Regulatory Affairs Consultant – Regulatory Lead
Parexel
Regulatory Affairs Manager – Drug Products
ClinChoice
full-time
Posted on:
Location Type: Remote
Location: Remote • Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead and contribute to the preparation, review, and submission of regulatory filings to FDA, EMA, and other authorities.
- Provide hands-on support for regulatory document authoring and compiling, balanced with broader strategic and operational guidance.
- Serve as a primary regulatory contact for clients, offering practical solutions for both development-stage and marketed products.
- Collaborate with global regulatory experts, technical teams, and clients to ensure aligned strategies and timely execution.
- Advise on regulatory requirements, risks, and timelines, helping clients navigate evolving regulatory landscapes.
- Support preparation for and participation in regulatory authority meetings.
- Mentor junior regulatory staff and share best practices across the consulting team.
Requirements
- Bachelor’s or advanced degree in a scientific or related discipline.
- 10+ years of Regulatory Affairs experience in the pharmaceutical industry, with significant exposure to both US and EU drug product submissions (INDs, NDAs/MAAs, variations, supplements).
- Strong understanding of regulatory requirements for drug development and lifecycle management.
- Proven ability to work directly with clients, translating regulatory requirements into actionable plans.
- Demonstrated balance of hands-on submission support and strategic regulatory guidance.
- Excellent communication, collaboration, and problem-solving skills.
Benefits
- excellent work-life balance
- quality-focused culture
- collaborative team environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory filingsregulatory document authoringINDsNDAsMAAsvariationssupplementsdrug developmentlifecycle management
Soft skills
communicationcollaborationproblem-solvingmentoringstrategic guidance
Certifications
Bachelor’s degreeadvanced degree
