Senior/Vice President of Regulatory Strategy

At Parexel, we believe in the impact we can have when our values align. Our shared mission is to enhance global health through innovative clinical trials, regulatory consulting, and market access solutions. Join us in making a real difference for patients around the world.

As a Senior/Vice President of Regulatory Strategy, you will lead transformative regulatory initiatives, guiding biopharma companies through intricate regulatory environments to deliver safer, more effective therapies globally. This is your chance to be at the forefront of innovation and contribute to shaping drug development.

You will:

1. Lead and execute strategic regulatory initiatives across various product types and global markets.
2. Provide expert advice to clients throughout the entire product lifecycle, from early development to post-marketing.
3. Utilize your scientific, technical, and commercial expertise to drive favorable regulatory outcomes.
4. Lead and collaborate with highly respected subject matter experts.
5. Serve as a thought leader in the industry, representing Parexel’s vision and values.
6. Embrace challenges with an innate curiosity and a passion for science and public health, making this role ideal for someone committed to making a difference.

A successful candidate will be recognized as a leader in their field with proven relationship-building skills with senior leaders in client organizations. You will have a deep understanding of our consulting frameworks and methodologies and provide comprehensive consulting services, mentoring others, and contributing to our knowledge base.

Project Execution

• Collaborate within teams or independently, based on project requirements.
• Lead conflict resolution and issue management within project guidelines.
• Prioritize and manage project and team workloads to meet objectives.
• Enhance project efficiency through proactive improvement initiatives.
• Leverage insights from past projects for efficient completion of current tasks.
• Deliver high-quality work, ensuring team outputs meet client expectations.
• Manage a variety of project engagements effectively.
• Work closely with project assistants to maintain accurate financial management.
• Offer guidance and mentorship to junior team members.

Thought Leadership

• Present at industry seminars and conferences based on recognized expertise.
• Contribute articles to professional publications and industry news.
• Review and ensure quality in thought leadership contributions from colleagues.
• Engage with industry associations and contribute to boards or committees.
• Facilitate improvements within Parexel’s business processes and service offerings.

Consulting Activities and Relationship Management

• Tailor consulting models to meet unique client needs and improve methodologies.
• Offer a broad range of technical and business consulting across various services.
• Ensure timely project activities while understanding factors affecting profitability and client satisfaction.
• Act as a trusted advisor to clients, resolving ambiguous issues effectively.
• Develop business solutions that address client-specific needs.
• Engage with senior management within client organizations and provide strategic insights.
• Deliver services that enhance client satisfaction and foster long-term relationships.
• Identify and capitalize on opportunities for further business growth.

Requirements

• Education: MD required.
• Experience: 15+ years in Clinical Development, Clinical Trial Design, and extensive regulatory knowledge.
• Previous regulatory agency experience required, ideally with a role such as Senior Medical Review Officer.
• In-depth experience in Endocrinology, Neuroscience, Rare Disease, or Immunology preferred.
• Ability to travel 20-30% for client and regulatory meetings is required.

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.