Vice President, Technical - Clinical Regulatory Affairs
New
Based in the United StatesFull-TimeVp
Salary not disclosed
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Job Details
- Experience
- 15+ years
- Required Skills
- Stakeholder management
Requirements
- MD or PhD required.
- 15+ years of experience in clinical development, clinical trial design, and regulatory strategy within pharma, biotech, or related environments.
- Prior experience with regulatory agencies (e.g., FDA, MHRA) in roles such as Medical Reviewer, Team Lead, or equivalent strongly preferred.
- Demonstrated expertise in authoring clinical and regulatory documentation for submissions and approvals.
- Strong understanding of global regulatory frameworks and clinical development processes.
- Experience in therapeutic areas such as neuroscience, rare disease, immunology, or endocrinology/metabolism is highly desirable.
- Exceptional leadership, communication, and stakeholder management skills, with experience engaging executive-level audiences.
- Ability to travel domestically and internationally (approximately 20–30%) as required.
Responsibilities
- Lead strategic regulatory and clinical consulting engagements across multiple client programs, providing high-level scientific and technical guidance throughout the product lifecycle.
- Act as a key advisor to senior client stakeholders, including executive leadership and health authorities, ensuring alignment on clinical development and regulatory strategy.
- Oversee project execution, ensuring quality, efficiency, and compliance with regulatory standards while guiding cross-functional teams of subject matter experts.
- Contribute to and lead thought leadership initiatives, including publications, industry presentations, and participation in scientific or regulatory forums.
- Support development and refinement of consulting methodologies, service offerings, and internal best practices to enhance organizational capability.
- Mentor and guide senior and junior team members, fostering expertise development and strengthening team performance.
- Identify business development opportunities within client engagements and support expansion of strategic relationships.
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