Regulatory Affairs Manager

Regulatory Affairs Manager

Location: On site in Venice FL

Monday-Friday 8am-5pm, some hours outside of this time frame

Salary: $110,000-$140,000/year

Position Overview: As the Regulatory Affairs Manager, you will collaborate closely with the leadership team to ensure compliance with applicable regulations and standards governing the manufacturing, labeling, marketing, and distribution of our products. Your primary focus will be on developing and implementing regulatory strategies to achieve successful and expedient product compliance and registrations worldwide.

Key Responsibilities:

Regulatory Compliance:

• Monitor and interpret federal, state, and international regulations relevant to the dietary supplement industry, including FDA regulations, DSHEA (Dietary Supplement Health and Education Act), GMP (Good Manufacturing Practices), GFSI, and labeling requirements.

Strategic Planning:

• Lead the development of regulatory strategies and implementation plans to ensure global compliance for new projects, product developments, and line extensions.

Knowledge Management:

• Stay informed about FDA, GFSI, and international regulations, guidance, and standards applicable to our products.
• Provide technical leadership and vision by interpreting emerging national and international regulatory trends.

Documentation and Submissions:

• Create and maintain comprehensive documentation related to regulatory compliance activities, including regulatory submissions, certifications, and correspondence with regulatory agencies.

Product Registration:

• Facilitate product registrations and certifications to support sales teams in increasing distribution in the USA and international markets.
• Collaborate with Sales teams to provide detailed formula information for private label opportunities.

Quality Assurance Collaboration:

• Collaborate with quality assurance teams to ensure adherence to regulatory standards throughout all stages of product development, manufacturing, and distribution.
• Participate in staff training on DSHEA compliance, cGMP, and SQF.

Qualifications:

• Bachelor's degree in Regulatory Affairs, Chemistry, Biology, or a related field.
• Proven experience in regulatory affairs within the dietary supplement or related industry.
• In-depth knowledge of FDA regulations, DSHEA, GMP, and GFSI.
• Strong organizational and project management skills.
• Excellent communication and collaboration abilities.