Vice President Regulatory Affairs

Company Overview:

Join a cutting-edge biotechnology company in Boston, committed to pioneering breakthrough therapies that address unmet medical needs. Our team is passionate about translating science into therapeutic solutions, and we are looking for a highly experienced Vice President of Regulatory Affairs to lead our regulatory strategy and guide us through key regulatory milestones.

Position Summary:

The Vice President of Regulatory Affairs will be responsible for overseeing and executing the company’s regulatory strategy across all phases of product development, from preclinical to commercial stages. This individual will play a critical role in ensuring successful regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs) with the U.S. Food and Drug Administration (FDA). The ideal candidate will have a strong background in FDA regulatory submissions, a comprehensive understanding of the biotechnology regulatory landscape, and an established record of working with global regulatory bodies.

Key Responsibilities:

• Develop, lead, and implement global regulatory strategies for the company’s pipeline products, with a focus on aligning with FDA and international regulatory requirements.
• Oversee the preparation, review, and submission of all regulatory filings, including INDs, NDAs, BLAs, and related submissions, ensuring compliance with regulatory standards.
• Collaborate closely with Research & Development, Clinical, Quality, and Manufacturing teams to ensure regulatory requirements are integrated into development and commercialization processes.
• Ensure compliance with all applicable FDA regulations and international regulatory requirements throughout the lifecycle of each product.
• Serve as the primary liaison with regulatory agencies (FDA, EMA, etc.), managing communications, submission responses, and regulatory meetings to facilitate timely approvals and support regulatory filings.
• Identify regulatory risks and provide strategic guidance on risk mitigation, regulatory pathways, and opportunities to accelerate development timelines.
• Establish and maintain robust regulatory processes and policies to support product development and commercialization objectives.

Required Qualifications:

• 15+ years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
• Proven experience with the FDA regulatory process, including IND, NDA, and BLA submissions and approval processes.
• Demonstrated experience in a senior regulatory leadership role, with a track record of effective cross-functional collaboration and team leadership.
• In-depth understanding of global regulatory standards and processes (e.g., FDA, EMA) and familiarity with working across all phases of drug development.
• Strong strategic and analytical skills, with the ability to manage complex projects, interpret regulatory guidelines, and provide actionable recommendations.
• Exceptional written and verbal communication skills, with the ability to effectively communicate regulatory concepts and strategies to both technical and non-technical stakeholders.

Preferred Qualifications:

• Advanced degree (PhD, PharmD, MD, or equivalent) in a related scientific discipline.
• Experience working with regulatory authorities outside of the U.S., including EMA and other international bodies.
• A proven ability to identify innovative regulatory solutions to support the advancement of complex biologic products.