Position Summary

The Vice President of Regulatory Affairs is responsible for directing the strategic planning and execution of activities needed to secure and maintain marketing authorization in the US and Canada. This role involves extensive interaction with regulatory agencies such as the FDA and Health Canada, seeking scientific advice, providing cross-functional leadership and authoring/reviewing submission documents for regulatory applications. This position reports to the Luvantas CEO and will work closely with Luvantas executives and Medytox Quality and Regulatory leaders to ensure products and business activities are in compliance with regulatory requirements and Medytox quality standards. The ideal candidate will have extensive experience building and leading regulatory teams and a successful record of approved regulatory submissions.

Key Responsibilities

• Accountable for the successful submission of the company’s lead BLA and Health Canada NDS.
• Ensure compliance with all applicable Luvantas and Medytox policies and North American regulatory requirements.
• Exercise broad based risk assessment regarding quality policies and practices and implementing effective changes.
• Provide quality oversight on CPO provider and 3PL distribution provider, to include in-market batch release.
• Ensure customer complaints are processed effectively and in collaboration with Medytox Quality team.
• Ensure that policy, practices, and leadership actions are aligned within each entity of Luvantas.  
• Understand Luvantas’s vision/mission and promote it within the organization.
• Select and develop regulatory and quality assurance talent in each entity and ensure that succession candidates exist for each key position.
• Successfully and efficiently plan and execute activities necessary to ensure compliance with FDA, Health Canada and other applicable health authorities.
• Interface externally with auditors, partners, regulators, and others as a credible, influential, and respected thought leader and company spokesperson.
• Understand relevant industry trends and guide leadership accordingly.
• Work effectively and collaboratively with the Medytox PV, RA and QA functions.

Required Skills/Abilities

• Bachelor’s degree with 10+ years’ Regulatory Leadership roles, advanced degree preferred.
• Experience in the biologics or pharmaceutical sector, with preference given to botulinum toxin CMC experience.
• Significant experience and understanding of GMP and principles of regulatory compliance.
• Experience managing in a global, multicultural organization.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Ability to manage onsite, hybrid and remote regulatory/quality assurance teams.
• Experience in hosting FDA/Health Canada audits.
• Regulatory experience with BLAs, NDAs and PMAs would be preferred.
• Ability and willingness to travel to South Korea, Canada and other locations as required.

Benefits and Compensation

• Competitive salary commensurate with experience.
• Generous benefits, through Insperity PEO.
• 4 weeks’ vacation and paid Holidays.
• Hybrid work schedule.