Job opening
Regulatory Affairs Manager
Filed under Staffing and Recruiting
Full job description
Exceptional Management Skills
Job Overview:
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 jill@cmcconsult.com