Vice President, Regulatory and Head of Regulatory Affairs

About the Role

The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance. This role serves as the primary liaison with global regulatory authorities and involves close collaboration with cross-functional teams and external partners to ensure the successful advancement of clinical programs.

Responsibilities

• Develop and implement comprehensive regulatory strategies to support the Company’s clinical development programs and ensure compliance with regulatory requirements.
• Align regulatory plans with product lifecycle, commercial objectives, and business priorities.
• Monitor global regulatory trends, guidance updates, and agency priorities to adapt strategies proactively and provide strategic insights to the organization.
• Lead the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, MAAs, briefing books, CTAs, DSURs, IBs, and others.
• Ensure compliance with all applicable regulatory requirements and guidelines, including those issued by the FDA, EMA, and other global regulatory agencies.
• Serve as the primary point of contact with regulatory agencies, managing communications, meetings, and negotiations to facilitate regulatory approvals.
• Ensure submissions meet the highest quality standards and are submitted on schedule.
• Oversee electronic submission vendor management and maintain accurate submission records.
• Partner with clinical development and operations, R&D, quality, and other cross-functional teams to provide regulatory guidance and support throughout the product development lifecycle.
• Oversee the company’s external regulatory advisors, consultants, and vendors to ensure relevant regulatory advice is provided for development programs.
• Identify and communicate potential regulatory risks and develop mitigation strategies to ensure program success.

Requirements

• Advanced degree (Ph.D., PharmD, MD, or equivalent preferred) in a scientific or regulatory discipline.
• Minimum of 15 years of experience in regulatory affairs within the biotech or pharmaceutical industry.
• Proven track record of successful IND, NDA/BLA submissions, interactions, and approvals.

Skills

• Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements.
• Demonstrated ability to manage complex, cross-functional projects with both internal and external stakeholders and regulatory vendors.
• Exceptional communication and interpersonal skills with the ability to think strategically and provide regulatory insights.
• Strong problem-solving and decision-making capabilities and attention to detail.
• Proficiency in regulatory submission software and tools.

Preferred Skills

• Experience working in a publicly traded biotech company.

Pay

The salary range for this position is $340,000–$370,000. Actual compensation within this range will be based on the experience and qualifications of the selected candidate.