Regulatory Affairs Manager

Job Summary

To support the growth of a pioneering microbiome science company, the full-time remote Regulatory Affairs Manager will manage regulatory submissions, ensure compliance with health regulations, and collaborate with cross-functional teams on product development.

Key responsibilities

• Manage regulatory submissions and maintain compliance with applicable health regulations
• Collaborate with product development teams to ensure regulatory requirements are met throughout the product lifecycle
• Monitor and interpret changes in regulations affecting the company's products and advise on necessary actions

Required qualifications

• Bachelor's degree in a relevant field such as life sciences or regulatory affairs
• Minimum of 5 years of experience in regulatory affairs within the health or biotech industries
• Proven knowledge of FDA and other regulatory agency guidelines
• Experience with regulatory submissions for dietary supplements or pharmaceuticals
• Strong understanding of clinical research and product development processes