USA_Regulatory Associate - Level 3
$45 - $49 per hourManpower Inc
Regulatory Affairs Senior Associate
Our client, a leading organization in the Consumer Healthcare/Pharmaceutical industry, is seeking a Regulatory Affairs Senior Associate to join their team. This role will support the U.S. Regulatory Affairs function, focusing on OTC product registrations and lifecycle management. The ideal candidate will bring strong attention to detail, excellent communication skills, and the ability to manage multiple priorities in a fast-paced environment.
Location: Warren, NJ
Pay Range: $45-49 per hour
1st shift
What's the Job?
- Execute OTC regulatory activities for new product registrations and lifecycle maintenance
- Develop regulatory strategies, submissions, and labeling for OTC products (monograph and NDA pathways)
- Review product claims, labeling, and promotional materials for regulatory compliance
- Ensure end-to-end compliance for assigned products, including maintaining technical records
- Collaborate with cross-functional and global teams to support regulatory initiatives and product launches
What's Needed?
- Bachelor's degree in Pharmaceutical Sciences, Life Sciences, or related field (or equivalent experience)
- 2–4 years of regulatory affairs experience, including OTC products and FDA submissions
- Strong knowledge of US FDA regulations, including OTC monograph, NDA, and CMC requirements
- Experience in product development, quality, or manufacturing environments
- Excellent communication, stakeholder management, and project prioritization skills
What's in it for me?
- Opportunity to work on innovative OTC product portfolios
- Exposure to end-to-end regulatory processes and new product launches
- Collaborative and cross-functional team environment
- Career growth within a dynamic regulatory affairs function
- Competitive compensation and benefits package
Vacancy posted 2 days ago
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