Regulatory Affairs Consultant - Clinical Regulatory Affairs

At Parexel, we are driven by a single purpose: to partner with our clients and help patients get access to life‑changing therapies faster.

We are currently seeking a Regulatory Affairs Consultant to join a dedicated client partnership. In this role, you’ll play a critical role in making that mission real—guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration.

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 is a dedicated partnership role with strong client trust and visibility to senior regulatory and clinical leadership.

This role focuses on regulatory strategy, health authority engagement, and compliance oversight—not site-level study coordination or patient-facing activities.

What You'll Do

• Develop and execute regulatory strategies for clinical development programs

• Lead health authority interactions and manage regulatory submissions (IND applications, annual reports, safety submissions)

• Conduct regulatory impact assessments and risk analysis

• Provide regulatory expertise on complex compliance issues

• Serve as the regulatory authority within cross-functional teams

• Ensure adherence to ICH guidelines and global regulatory pathways

Required Qualifications

• Minimum 5+ years of experience in regulatory affairs, with demonstrated expertise in health authority strategy and regulatory submissions to include deep understanding of regulatory strategy and health authority engagement.

• Strong knowledge of clinical development regulations

• Proven experience with IND applications, annual reports, and safety submissions (IND 120, IND 130, etc.)

• 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

• Strong written and verbal communication skills

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

• Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages.

• Experience with other global Health Authorities and applicable regulations are strongly preferred

Why This Role

• Serve as the regulatory leader for a major pharma client with direct visibility to senior regulatory and clinical leadership

• Deepen your expertise in health authority strategy and regulatory submissions

• Work in a dedicated partnership model with strong client trust

If you're passionate about regulatory strategy and want to make an impact at the health authority level, we'd love to hear from you.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.