Parexel

Parexel

Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs

United States - Remote · Senior

Sponsorship not specifiedDetected 13 days ago
Clinical TrialsFDA RegulatoryLeadershipCommunicationRegulatory Affairs

About the role

  • 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.

Responsibilities

  • Develop and execute regulatory strategies for clinical development programs
  • to partner with our clients and help patients get access to life‑changing therapies faster.

Requirements

  • Strong knowledge of clinical development regulations
  • Strong knowledge of ICH guidelines and global regulatory pathways
  • Familiarity with electronic submission systems (e-STARs, etc.)
  • Ability to work independently on regulatory matters with minimal supervision
  • Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages.

Nice to have

  • A minimum of a bachelor's degree in a scientific or technical discipline, advanced degree strongly preferred

Compensation

  • Lead health authority interactions and manage regulatory submissions (IND applications, annual reports, safety submissions)
  • Proven experience with IND applications, annual reports, and safety submissions (IND 120, IND 130, etc.)

Benefits

  • At Parexel, we all share the same goal - to improve the world's health.
  • As a Regulatory Affairs Consultant, you will be the strategic regulatory leader driving compliance and health authority strategy for a major pharmaceutical client's clinical portfolio.
  • This role focuses on regulatory strategy, health authority engagement, and compliance oversight-not site-level study coordination or patient-facing activities.
  • Experience with other global Health Authorities and applicable regulations are strongly preferred
  • Deepen your expertise in health authority strategy and regulatory submissions

Company info

  • When our values align, there's no limit to what we can achieve.
  • We are currently seeking a Regulatory Affairs Consultant to join a dedicated client partnership.
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.