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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