Overview:

Our client is a newly established medical aesthetics company dedicated to introducing innovative solutions to the North American market. They are a subsidiary of a globally recognized biopharmaceutical company, known for its strong history of innovation in the medical aesthetics industry.

The Vice President / Director of Quality Assurance and Regulatory Affairs is responsible for directing the strategic planning and execution of activities, with the parent company, 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 company’s CEO and will work closely with executives and the parent company’s Quality and Regulatory leaders to ensure products and business activities are in compliance with regulatory requirements and the parent company’s quality standards. The ideal candidate will have extensive experience building and leading regulatory teams and a successful record of approved regulatory submissions.

Responsibilities:

• Accountable for the successful submission of the company’s lead BLA and Health Canada NDS.
• Ensure compliance with all applicable company 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, per company guidelines.
• Ensure customer complaints are processed effectively and in collaboration with Quality team.
• Ensure that policy, practices, and leadership actions are aligned within each entity of the company.
• Understand company’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 company’s PV, RA and QA functions.

Qualifications:

• Bachelor’s degree with 10+ years’ Quality/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