Head of Regulatory Affairs - Executive Director / Vice PresidentJob title is “Head of Regulatory Affairs - Executive Director / Vice President

About the Company

i-Pharm is partnered with a global mid-sized pharmaceutical firm seeking to expand its US presence and R&D function. Company has approved products across 10 therapeutic areas.

About the Role

Seeking an experienced and strategic Executive Director / Vice President of Regulatory Affairs to lead the development, execution, and oversight of US regulatory strategies for both development and commercial-stage products. This individual will serve as a key regulatory leader and liaison between internal cross-functional teams and external stakeholders, including regulatory agencies and alliance partners. The role requires both high-level strategic thinking and hands-on expertise in regulatory submissions, compliance, and life cycle management to support our mission of delivering meaningful health solutions to patients in the US.

Responsibilities

• Develop and implement US regulatory strategies for investigational and marketed products to ensure timely and efficient regulatory approvals.
• Lead the preparation, submission, and maintenance of high-quality regulatory documents (e.g., INDs, CTAs, NDAs, MAAs, BLAs, supplements, annual reports) in compliance with health authority requirements.
• Serve as the primary liaison with regulatory agencies (e.g., FDA, EMA, PMDA) to negotiate, obtain guidance, and manage submissions and approvals.
• Provide strategic input to cross-functional project teams including Clinical, CMC, Quality, Medical Affairs, and Commercial on regulatory requirements, timelines, and risks.
• Evaluate regulatory impacts of changes to manufacturing, labeling, supply chain, and quality systems, and support post-approval lifecycle activities.
• Lead interactions with external partners and collaborators to ensure aligned regulatory strategies and execution.
• Act as liaison with Global Regulatory and Development colleagues in Europe to ensure alignment across the organization.
• Stay current with global regulatory guidelines and trends and proactively identify changes that could impact regulatory strategy or business objectives.
• Oversee regulatory input on promotional materials, product labeling, and advertising to ensure compliance with applicable regulations.
• Participate in industry and policy working groups to influence and stay informed of evolving regulatory landscapes.

Qualifications

• Bachelor’s degree in a scientific, health policy, or related field; Master’s or advanced degree preferred.
• 10+ years of regulatory affairs experience in the pharmaceutical or biotechnology environments.
• Demonstrated success in leading regulatory strategy and operations for clinical development and marketed products.
• Deep knowledge of FDA, EMA, ICH, and global regulatory frameworks; experience with digital health, telemedicine, or combination products is a plus.
• Proven ability to interface effectively with regulatory agencies and to lead cross-functional project teams in a fast-paced, matrixed environment.
• Exceptional communication, strategic thinking, and leadership skills.
• Regulatory Affairs Certification (RAC) or equivalent is desirable.