JOB PROFILE VICE PRESIDENT REGULATORY AFFAIRS AND QUALITY ASSURANCE
OVER THE COUNTER AND NUTRACEUTICAL PRODUCTS
MOORESVILLE, NORTH CAROLINA
A leading innovator, developer and manufacturer of OTC and nutraceutical products. The company is a leader in great-tasting, high-quality alternative oral dosage formats, including gummies, chews, and lozenges.
This newly created position following several acquisitions, reports to the Chief Executive Officer and works closely with the Chief Technology Officer. As a member of the Senior Leadership Team, you will work closely with the CEO and other members of the Senior Leadership Team to ensure successful attainment of all business goals and objectives.
Your basic role and mission is to define strategy and direction of the Regulatory and Quality functions within the business portfolio. You will define and execute the regulatory filing and clinical support strategy for the OTC chewable gel project, define and execute appropriate Quality and Regulatory systems, define and execute the QA system to support post market requirements and maintain pre and post market QA and Regulatory Systems.
We seek a strategic and tactical RA/QA professional who is comfortable working in a middle-market, high-growth environment. The incumbent will have a “roll-up your sleeves” approach needed in a nimble company. You will be an action-oriented, driven professional with the ability to lead by persuasion and example. The perfect candidate will have a proven track record in large pharma with successful regulatory filings and pharmaceutical applications, blended with an entrepreneurial spirit and successful transition into a smaller company.
· Serve as primary contact for regulatory agencies.
· Be adept at effectively influencing the FDA and clients including large pharma and FMCG companies.
· Have significant regulatory experience in leading interactions with the FDA and successfully filing NDAs.
· Have experience in leading the development of robust FDA filings and integrating with the project team to guide development of the data needed to support the filings.
· Have a current and extensive network of connections across the industry and FDA.
· Provide both strategic direction as well as drive/contribute to the hands-on execution needed in a medium sized company.
· Have experience establishing and maintaining QA systems necessary to support marketing of drugs.
· Be a collaborative leader with the proven ability to work across functional boundaries, effectively engage teams and deliver results.
· Support and mentor the current regulatory and quality team across the business portfolio.
· Possess strong planning and organizational skills to insure goals and objectives are met or exceeded.
· Be familiar with OTC drug monographs.
· Be familiar with US DSHEA legislation.
· Have experience working with the FDA on Rx-OTC switch.
· We seek a seasoned RA/QA executive with a minimum of 15 years of experience in the pharmaceutical industry. You should have extensive experience as primary contact for regulatory agencies.
· We seek a professional with an undergraduate degree. An advanced life sciences degree (PhD) is preferred. MBA desirable.
· We seek a well-rounded innovative and entrepreneurial executive with a solid, demonstrable track- record of accomplishments in both regulatory and quality functions within large and small pharma.
· You must possess the ability to lead by influence, drive strategic initiatives and lead the development of robust FDA filings. You must possess the ability to integrate with the project team to guide development of the required data to support the filing.
· We seek a well-rounded executive who is adept at being a RA/QA adviser and capable of adding significant value as a senior executive. You will have the ability to think strategically, be a pro-active problem solver, and drive FDA filing success.
· For best fit, you must be a results-oriented, take-charge, hands-on, and mature leader. You should be highly professional, an excellent communicator, approachable, with the ability to lead through persuasion and example. You must possess uncompromising values, integrity and work ethic.
A competitive compensation package will be designed to attract outstanding talent and will include a base salary, incentive plan an attractive benefits package, equity participation.
Zingaro & Company is recognized as a premier retained executive search consulting firm specializing in the healthcare industry. Our firm has the proven ability to successfully search and select senior-level management for our clients. Our team collectively has over 50 years of staff, line, and recruiting experience within the pharmaceutical, pharmaceutical services, medical device, diagnostics, and biotechnology industries.