VP - Head of Regulatory Affairs [Relocation Opportunity - Cayman Islands]

[Relocation Opportunity - Cayman Islands]

We are working with a Cayman based Pharmaceutical distributor that is looking to hire a VP, Head of Regulatory Affairs. This person will be responsible for leading and managing all regulatory activities.

The role requires a deep understanding of FDA, DEA, and state pharmacy board regulations, as well as experience in working with regulatory agencies to facilitate licensing, compliance, and product distribution approvals.

Key Responsibilities:

• Develop and oversee the company’s regulatory strategy to ensure compliance with all applicable laws and regulations.
• Serve as the primary liaison with regulatory agencies, including the FDA, DEA, state boards of pharmacy, and other governing bodies.
• Ensure timely and successful submission of regulatory filings, licenses, and permits required for pharmaceutical distribution operations.
• Provide leadership and guidance on regulatory risk assessment, mitigation strategies, and industry best practices.
• Monitor and interpret evolving regulatory requirements and provide proactive guidance to senior leadership.
• Develop and implement compliance programs, policies, and training to ensure adherence to regulatory requirements.
• Lead regulatory due diligence efforts for new business initiatives, partnerships, and acquisitions.
• Represent the company in industry associations and forums to advocate for favorable regulatory policies.
• Oversee audits, inspections, and interactions with regulatory authorities, ensuring timely and effective responses.
• Partner with internal teams including Quality, Legal, Operations, and Commercial to align regulatory objectives with business goals.

Qualifications & Experience:

• Bachelor’s degree in a relevant field (Pharmacy, Regulatory Science, Life Sciences, or related discipline); advanced degree preferred.
• 10 years of regulatory affairs experience in the pharmaceutical, biotech, or healthcare distribution sector.
• Extensive knowledge of FDA, DEA, and state pharmacy board regulations governing pharmaceutical distribution.
• Proven leadership experience in regulatory affairs with a track record of successful regulatory submissions and compliance management.
• Strong relationships with regulatory agencies and industry organizations.
• Exceptional problem-solving, analytical, and strategic thinking skills.
• Excellent communication and interpersonal skills with the ability to influence and collaborate across all levels of the organization.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities effectively.

Preferred Qualifications:

• Experience working in a senior regulatory affairs role within a pharmaceutical distribution or wholesale company.
• Familiarity with Good Distribution Practices (GDP) and Drug Supply Chain Security Act (DSCSA) regulations.
• Experience managing regulatory matters related to controlled substances and specialty pharmaceuticals.
• Strong business acumen with the ability to align regulatory strategies with corporate objectives.