Vice President, Regulatory Strategy

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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.

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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!

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