Regulatory Affairs SME
About The Position
Tunnell Consulting is seeking a Regulatory Affairs Subject Matter Expert (SME) with deep experience in soft gelatin (softgel) dosage forms to lead regulatory strategy and compliance activities for one of their clients. This role will support product development, commercialization, and lifecycle management across global markets. The project is remote, estimated for 6 months, and requires 20-40 hours per week. The SME will serve as a key regulatory advisor, ensuring products meet all applicable requirements for dietary supplements, OTC, or pharmaceutical products, with a strong focus on labeling, claims, and manufacturing compliance.
Requirements
- Bachelor’s degree in a scientific, regulatory, or related field
- 8+ years of Regulatory Affairs experience in pharma, biotech, or dietary supplements
- Strong expertise in soft gelatin (softgel) dosage forms required
- Deep knowledge of U.S. FDA regulations and relevant global requirements
- Experience with labeling, claims review, and compliance (supplements or OTC preferred)
- Familiarity with cGMP and manufacturing processes
- Proven ability to work cross-functionally and influence stakeholders
- Strong communication, analytical, and problem-solving skills
Nice To Haves
- Advanced degree preferred
Responsibilities
- Serve as the Regulatory Affairs SME for soft gelatin (softgel) formulations and manufacturing operations
- Develop and execute regulatory strategies to support product development, commercialization, and lifecycle management activities
- Ensure compliance with U.S. FDA and global regulatory requirements (e.g., 21 CFR Part 111/210/211, labeling regulations) and post-approval change management expectations
- Review and approve product labels, claims, and marketing materials for regulatory compliance
- Support product registrations, submissions, and ongoing lifecycle management activities
- Partner cross-functionally with R&D, Quality, and Manufacturing to ensure regulatory alignment throughout development
- Assess regulatory impact of deviations, CAPAs, change controls, and manufacturing changes
- Provide regulatory guidance on formulation changes, manufacturing process updates, technical transfers, and global market entry
- Monitor and interpret regulatory changes and communicate impact to stakeholders
- Support audits, inspections, and regulatory inquiries
- Maintain accurate regulatory documentation and ensure audit readiness
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What This Job Offers
Job Type
Part-time
Career Level
Senior
