Regulatory Affairs Senior Manager
Regulatory Affairs Senior Manager (OTC)
📍 Warren, NJ (Onsite)
📅 12+ Month Contract
💰 $73-$76/hour
We're hiring a Regulatory Affairs Senior Manager to support OTC regulatory activities, including new product registrations and lifecycle management for a leading consumer healthcare/pharma portfolio.
This is a high-impact role working cross-functionally to drive regulatory strategy, ensure compliance, and support product launches in the U.S. market.
What You'll Be Doing
- Lead U.S. regulatory strategy for OTC products, ensuring timely approvals and successful product launches
- Support new product registrations and lifecycle maintenance across the portfolio
- Develop and review regulatory submissions, labeling, and artwork in line with FDA and OTC monograph requirements
- Partner with cross-functional teams on claims, advertising, and promotional materials to ensure compliance
- Prepare and manage regulatory submissions (briefing books, supplements, annual reports, agency responses)
- Interface directly with the FDA, including responding to inquiries and supporting meetings
- Identify regulatory risks and changes, providing proactive guidance and mitigation strategies
- Drive process improvements and best practices across regulatory operations
What We're Looking For
- Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or related field
- 8+ years of Regulatory Affairs experience
- Strong experience with:
- FDA regulations
- OTC monograph products
- CMC (Chemistry, Manufacturing & Controls)
- Proven ability to lead regulatory strategy for product launches
- Strong communication and stakeholder management skills
- Experience working in cross-functional, fast-paced environments
Nice to Have
- Advanced degree (PharmD, MS, PhD, etc.)
- Experience at a global pharmaceutical or consumer health company
- Direct experience managing FDA interactions and submissions
- Project management and leadership experience across global teams
Why This Role?
- High visibility role supporting U.S. product launches and regulatory strategy
- Opportunity to work on a diverse OTC portfolio
- Collaborative, cross-functional environment with strong impact on business outcomes
📩 Interested or know someone who would be a fit? Send me a message to learn more.
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
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