Regulatory Affairs Manager

CMC Consultants, Inc.; Niles (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

CMC Consultants, Inc. is seeking an experienced Regulatory Affairs Manager to lead a diverse portfolio of FDA-regulated products, including OTC monograph drugs, cosmetics, dietary supplements, and Class I medical devices.

You will provide regulatory strategy, review labeling and ingredients, coordinate submissions, and partner with R&D, Marketing and Quality teams to bring products to market. 5+ years of regulatory affairs experience are required.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field.
• 5+ years of regulatory affairs experience in FDA-regulated consumer healthcare products.
• Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices.

Responsibilities

• Regulatory Strategy and Compliance
• Develop and implement regulatory strategies and ensure compliance with FDA requirements.
• Product Development Support
• Partner with R&D, Marketing and Quality teams during product development and commercialization
• Review product formulations, ingredients, specifications, and labeling for regulatory compliance.
• Labeling & Claims Review
• Regulatory Documentation and Submissions
• Quality & Risk Management
• Cross Functional Leadership
• Post-Market Surveillance & Adverse Event Reporting

Skills

Regulatory strategy

FDA regulations

Leadership

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field

Job description

Our global client has a long and reputable history of producing and marketing high quality brands and delivering customer satisfaction as a leader in the OTC pharmaceutical industry. We are seeking an experienced Regulatory Affairs Manager to lead a diverse portfolio of FDA regulated products including OTC monograph drug products, cosmetics, dietary supplements, and Class 1 medical devices.

The ideal candidate will possess strong knowledge of U.S. FDA regulations, leadership skills, and experience bringing regulated consumer health care products to market.

Key Responsibilities

• Regulatory Strategy and Compliance
• Develop and implement regulatory strategies and ensure compliance with FDA requirements.
• Product Development Support
• Partner with R&D, Marketing and Quality teams during product development and commercialization
• Review product formulations, ingredients, specifications, and labeling for regulatory compliance.
• Labeling & Claims Review
• Regulatory Documentation and Submissions
• Quality & Risk Management
• Cross Functional Leadership
• Post-Market Surveillance & Adverse Event Reporting

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field. Advanced degree in scientific discipline a plus.
• 5+ years of regulatory affairs experience in FD-regulated consumer healthcare products.
• Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices.

Contact

If interested in a career with an outstanding organization, please send your resume with salary history and cover letter to [e-mail]