Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

Respected provider of top-quality services

Industry
Consumer Services

Type
Privately Held

About the Role

The Company is seeking a Head of Regulatory Affairs to take on a pivotal leadership role in driving U.S. regulatory strategy and execution for a diverse range of products, including OTC drugs, cosmetics, and medical devices. The successful candidate will be responsible for the full regulatory lifecycle, from strategy to post-market activities, ensuring that all products meet FDA standards and are in line with commercial objectives. This role demands a high level of expertise in FDA regulations, particularly in the areas of labeling, claims, and formulation, and requires a strong background in regulatory affairs within the U.S. market. Key responsibilities for the Head of Regulatory Affairs include leading the U.S. regulatory strategy, owning end-to-end lifecycle management, and partnering with cross-functional teams to support business growth. The ideal candidate will have a minimum of 7 years' experience in regulatory affairs, with a proven track record in regulatory strategy, submissions, and compliance. Strong leadership skills and the ability to drive cross-functional collaboration are essential. A Bachelor's degree is required, with a preference for an advanced degree in a related field, and experience in pharma and/or dermatology environments is a plus. The role also involves monitoring and interpreting FDA updates, managing post-market surveillance programs, and maintaining relationships with regulatory authorities and industry stakeholders.

Travel Percent
Less than 10%

Functions

• Product Management