Manager

Position Summary

The Director of Regulatory Affairs will serve as the company’s senior regulatory leader, responsible for all regulatory compliance and strategy across product development, manufacturing, labeling, and marketing. This role ensures that all Fruit of the Earth products meet or exceed applicable FDA ( OTC drug, cosmetic and  food) and international regulatory standards.

As a key member of the leadership team, the Director will partner closely with R&D, Quality, Operations, Legal, and Commercial functions to support innovation and growth while managing regulatory risk.

Key Responsibilities

• Regulatory Strategy & Leadership
  • Lead the company’s global regulatory strategy for OTC drug, sunscreen, skin care, food, and personal beauty categories.
  • Serve as the primary regulatory liaison with the FDA and other domestic/international regulatory bodies.
  • Advise senior leadership on evolving regulatory landscapes and their business implications.
• Compliance Oversight
  • Ensure compliance with all applicable regulations including FDA OTC monographs, cGMPs, labeling requirements, and product claims.
  • Oversee product registrations, drug listings, facility registrations, and annual renewals.
  • Review and approve labeling, packaging, and advertising for regulatory accuracy.
• Product Development Support
  • Partner with R&D and Product Development teams to ensure new product concepts meet regulatory requirements early in the design phase.
  • Evaluate ingredients, formulas, and claims for compliance with U.S. and international standards.
• Operational & Quality Integration
  • Work closely with Manufacturing and Quality to ensure continued compliance with OTC drug, cosmetic and food manufacturing requirements.
  • Support internal audits and inspections; lead regulatory aspects of FDA, third party certifications and/or customer audits.
• Team Leadership & Development
  • Build and lead a small but high-impact regulatory team with expertise in OTC, cosmetic, food, drug, and international compliance.
  • Develop and implement processes to scale regulatory capabilities as the company grows.

Qualifications

• Bachelor of Science degree, preferably in chemistry, biology, pharmacy, or related field; advanced degree preferred.
• Minimum 10 years of progressive regulatory experience within OTC, personal care, food, drug, or cosmetic manufacturing.
• Deep working knowledge of FDA OTC monographs, food regulations, and product registration requirements.
• Experience managing regulatory submissions, compliance documentation, and FDA interactions.
• Demonstrated ability to work cross-functionally and influence at senior levels.
• Excellent written and verbal communication skills, with a pragmatic, solution-oriented approach.

Key Competencies

• Strategic thinker with operational rigor.
• Hands-on leadership style suited to a mid-sized, fast-moving organization.
• Strong business acumen and ability to balance compliance with commercial priorities.
• Credibility and confidence to represent the company before regulators, customers, and partners.

Salary : $120,000 - $160,000