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
Additional Information
- City
- Morristown
- State
- NJ
- Zip
- 07960
- Country
- United States
- Job Type
- Product Management
- Mobile Friendly Apply
- No
- Html Jobs
- Yes
- Url
- https://click.appcast.io/t/0OwQlqM1LOpgaavkV-PTN72y_Qd-HkHTCJ-0z8QOb_Cor38pmmjsPpaz5lAj9jT_HV2j14aD5RdJm8CX9ThIFQ==
- Cpc
- 0.22