We are working with a Cayman based company that is looking to hire a VP, Head of Regulatory Affairs.
This person will be responsible for leading and managing all regulatory activities.
Salary Range: US$150-200k 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Supply Chain, Administrative, and Health Care Provider
Industries Pharmaceutical Manufacturing
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