Vice President of Regulatory Affairs and Quality (Hybrid)

Vice President of Regulatory Affairs and Quality

OTC drugs, medical devices, dietary supplements and cosmetics.

Vice President of Regulatory Affairs and Quality will lead the strategic and operational direction of the company’s quality and regulatory functions across its full portfolio of over-the-counter (OTC) healthcare products. This executive will ensure that all products and third-party manufacturers comply with applicable quality standards and regulatory requirements, while supporting innovation, brand growth, and operational excellence.

Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance and paid PTO.Does this position match your future career goals? Then this opportunity could be the right fit for you.

Why should you apply?

• Excellent work environment with growth opportunities
• Competitive Salary
• Top Benefits

RESPONSIBILITIES

• Serve as the company’s Management Representative and Quality Representative (QR/MR), overseeing the implementation and maintenance of the Quality Management System (QMS).
• Report to executive leadership on QMS performance, effectiveness, and areas for improvement.
• Act as the primary liaison with external regulatory bodies and industry partners.
• Direct and manage the Quality Assurance, Regulatory Affairs, and Medical Affairs teams.
• Develop and execute compliance strategies that support new product development, brand initiatives, and operational goals.
• Promote regulatory and quality awareness across all departments.
• Partner with Marketing, Product Development, Packaging, Legal, and Operations to ensure product and labeling claims meet regulatory standards.
• Provide guidance on clinical studies, customer service protocols, and pharmacovigilance activities.
• Lead quality and cGMP compliance efforts for OTC drugs (monograph and NDA/ANDA), medical devices, dietary supplements, and cosmetics.
• Promote the development of a global regulatory strategy for products registration
• Provide regulatory counsel to different groups within company
• Maintain regulatory documentation including NDAs, 510(k)s, and other submissions.
• Monitor global regulatory developments and communicate relevant updates to internal stakeholders.

QUALIFICATIONS

• Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred.
• Minimum 15 plus years of experience in Quality Assurance and/or Regulatory Affairs within the consumer packaged goods (CPG) or healthcare industry.
• Demonstrated success in NDA or 510(k) submissions and lifecycle management.
• Global experience is a strong plus.
• Regulatory Affairs experience in the Pharmaceutical Manufacturing Industry
• Deep understanding of U.S. OTC drug regulations, including NDA and monograph pathways.
• Expertise in FDA and FTC requirements for product claims and advertising.
• Strong command of cGMP standards for manufacturing and distribution.
• Proficient in ISO 13485:2016 and international regulatory frameworks (Canada, EU, Latin America).
• Familiarity with U.S. clinical research methodologies.
• Exceptional written and verbal communication skills.