Senior/Vice President, Technical - Clinical Regulatory Affairs

Responsibilities

• Provide high-level technical and strategic consulting to biopharmaceutical and medical device clients to navigate complex regulatory landscapes.
• Lead project execution for small or large engagements, ensuring quality work that meets client and organizational expectations.
• Act as a trusted advisor to client executive management and C-suite leaders, often addressing unprecedented regulatory issues.
• Drive thought leadership by authoring industry articles, presenting at seminars, and contributing to professional societies or industry boards.
• Mentor and provide guidance to junior staff and other Regulatory Strategy team members.
• Identify and exploit opportunities for follow-on business and new service offerings.

Requirements

• MD or PhD degree is required.
• 15+ years of expert-level industry or regulatory experience in Clinical Development, Clinical Trial Design, or Clinical Strategy.
• Proven experience authoring clinical sections of regulatory applications.
• Previous experience with a regulatory agency (such as the FDA or MHRA) in a senior medical review or leadership role is strongly preferred.
• Ability to travel 20-30% domestically and/or internationally for client meetings and conferences.

Preferred Qualifications

• Extensive expertise in Neuroscience, Rare Disease, Immunology, or Endocrinology/Metabolism.
• Demonstrated "rainmaking" skills and established relationships at senior levels within client organizations.
• Experience serving as a Health Authority Medical Review Team Lead or Senior Medical Review Officer.

About the Company

Parexel is a global leader in clinical research, dedicated to helping companies bring better, safer products to market. We combine scientific expertise with empathy to accelerate therapies that change patients' lives. We offer a supportive, inclusive, and flexible remote work environment that fosters continuous learning and professional growth.