Vice President, Technical - Clinical Regulatory Affairs in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Vice President, Technical - Clinical Regulatory Affairs based in the United States.

This senior leadership role sits at the intersection of clinical development, regulatory strategy, and scientific innovation, guiding complex programs across the full product lifecycle. You will serve as a trusted expert advisor to biopharma clients, helping shape clinical and regulatory pathways that accelerate the development of safe and effective therapies. Operating at an executive level, you will lead high-impact engagements, influence strategic decisions, and represent deep technical expertise in discussions with senior stakeholders and health authorities. The role combines hands-on regulatory consulting with thought leadership, offering the opportunity to shape industry practices and methodologies. You will also mentor internal teams and contribute to the evolution of consulting frameworks within a highly specialized global environment. This is a remote-first position with meaningful client interaction and occasional travel. It is ideal for a seasoned leader passionate about advancing public health through regulatory excellence.

• 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.

This role requires deep expertise in clinical development and regulatory affairs, supported by advanced scientific training and extensive industry experience. Candidates should bring strong leadership capabilities, credibility with regulatory bodies, and a proven ability to operate at a strategic advisory level.

• 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.

• Competitive executive compensation aligned with experience and impact
• Performance-based bonus eligibility (where applicable)
• Remote-first flexibility with travel for key client and leadership engagements
• Opportunity to work on high-impact, global clinical and regulatory programs
• Strong professional development and thought leadership opportunities
• Collaborative, expert-driven environment with global senior stakeholders
• Inclusive workplace with comprehensive employment protections and equal opportunity policies