Vice President, Regulatory Strategy

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Vice President, Regulatory Strategy in United States.

This is a high-impact executive opportunity for a seasoned regulatory leader passionate about shaping the future of pharmaceutical and biotech innovation. In this role, you will lead complex regulatory strategy initiatives across global development programs while advising senior client stakeholders on critical business and regulatory decisions. You will play a central role in driving practice growth, developing innovative consulting capabilities, and positioning the organization as a trusted authority in regulatory strategy. Working in a collaborative and globally connected environment, you will influence cross-functional teams, mentor senior talent, and contribute to transformative healthcare solutions. This position is ideal for a strategic thinker with deep scientific and regulatory expertise who thrives in a fast-paced, client-facing consulting environment. The role also offers the opportunity to engage with emerging trends including AI-enabled regulatory transformation and global harmonization initiatives.

Accountabilities

• Lead enterprise-level regulatory strategy engagements for pharmaceutical and biotech clients across multiple therapeutic areas and product modalities.
• Serve as a trusted advisor to VP and C-suite executives, providing strategic guidance on complex regulatory pathways, accelerated approvals, and global development programs.
• Drive practice growth through business development initiatives, strategic client partnerships, and expansion of consulting capabilities and service offerings.
• Collaborate with cross-functional teams to deliver integrated solutions across regulatory, clinical, and quality domains.
• Shape innovative methodologies and thought leadership initiatives related to evolving regulatory frameworks, AI-enabled submissions, and international harmonization efforts.
• Oversee high-quality project delivery standards while balancing profitability, operational excellence, and client value.
• Mentor and develop senior regulatory professionals, supporting succession planning and long-term team capability building.
• Represent the organization at industry conferences, regulatory forums, and external engagements to strengthen market presence and influence.
  
  

Requirements

• 20+ years of progressive regulatory affairs experience within both consulting and biopharmaceutical environments.
• Proven expertise leading regulatory strategies across all phases of drug development, from pre-IND through post-market activities.
• Strong knowledge of global regulatory agencies and frameworks, including FDA, EMA, Health Canada, PMDA, and international harmonization initiatives.
• Demonstrated experience supporting multiple product types such as biologics, small molecules, cell and gene therapies, and combination products.
• Track record of advising executive-level stakeholders and leading high-value client engagements.
• Experience managing regulatory teams, practice operations, and business development initiatives with revenue accountability.
• Advanced degree in life sciences, regulatory affairs, or related discipline required; MBA, RAC certification, or similar credentials preferred.
• Strong communication, leadership, analytical, and strategic thinking skills with the ability to influence diverse stakeholders.
• Recognized industry thought leadership through publications, conference speaking engagements, or regulatory advisory contributions.
  
  

Benefits

• Competitive compensation package with performance-based bonus opportunities
• Comprehensive medical, dental, and vision insurance plans
• 401(k) retirement plan with employer matching
• Flexible paid time off policy
• Health savings account with employer contributions
• Flexible spending accounts for healthcare and dependent care expenses
• Employee Assistance Program (EAP)
• Employer-paid short-term and long-term disability coverage
• Remote work flexibility within the United States
• Ongoing professional development and leadership growth opportunities.
  
  

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.