Senior Regulatory Affairs Associate - Generalist

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking a highly organized and collaborative Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities.

Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist / Senior Associate plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes.

The Regulatory Affairs Generalist / Senior Associate provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills.

Key Responsibilities

1. Regulatory Archiving & Documentation Management

Maintain U.S. regulatory archive logs, including:

Recording new submissions.

Archiving regulatory authority correspondence.

Upload and manage correspondence from global partners for assigned programs.

Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools.

Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations.

2. Clinical Regulatory Support

Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation.

Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support I