Senior Regulatory Affairs Lead - Global Partnerships

Parexel; Boston (MA); Remote; USD 100,000 - 150,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to provide end-to-end regulatory support for partnered assets across clinical, submission, and post-approval activities. The role interfaces with alliance stakeholders to ensure regulatory excellence and compliant program execution.

The ideal candidate will have strong organizational skills, cross‑functional collaboration experience, and the ability to manage multiple regulatory deliverables in a dynamic, multi‑team

Qualifications

• 3+ years of related regulatory affairs experience in the pharmaceutical/biotech industry.
• Bachelor’s Degree in a scientific or technical discipline required; advanced degree preferred.

Responsibilities

• Maintain U.S. regulatory archive logs and ensure audit readiness across submissions and correspondence.
• Support FORM FDA 1572 waivers and regulatory documentation for clinical trials.
• Draft administrative components of regulatory submissions (FDA forms, cover letters, metadata).
• Coordinate submission planning, publishing workflows, and cross-functional review cycles.
• Prepare materials for Global Regulatory Team (GRT) meetings and alliance discussions.
• Contribute to drafting and reviewing regulatory submissions across development stages.
• Support post-approval regulatory maintenance including periodic reports (PADERs, NDA Annual Reports).

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Communication skills

Problem-solving

English proficiency

Education

Bachelor’s Degree in a scientific/technical discipline

Job description

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to provide end-to-end regulatory support for partnered assets across clinical, submission, and post-approval activities. The role interfaces with alliance stakeholders to ensure regulatory excellence and compliant program execution.

The ideal candidate will have strong organizational skills, cross‑functional collaboration experience, and the ability to manage multiple regulatory deliverables in a dynamic, multi‑team