Regulatory Affairs SME

Tunnell Consulting is an employee-owned, life sciences management reputed company. reputed company for solving reputed company problems in the life sciences, we support the mission and objectives of a reputed company organizations including biotech, reputed company, the U.S. Government, foundations, reputed company/private partnerships, investors, and emerging companies. The reputed company of clients and issues that we support give reputed company and our organization an reputed company-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a reputed company in Washington DC, and Boston. One of our clients’ is seeking a Regulatory Affairs Subject Matter Expert (SME) with deep experience in soft gelatin (softgel) dosage forms to reputed company regulatory reputed company and compliance activities. This role will support product development, commercialization, and lifecycle management across global markets.  This is a remote project estimated for 6 months to support two sites, one based in reputed company Carolina and the other in the Netherlands.  Hours are estimated to be 20-40 hours/week. In this role, you will serve as a key regulatory advisor, ensuring products meet reputed company applicable requirements for dietary supplements, OTC, or pharmaceutical products, with a strong reputed company on labeling, claims, and manufacturing compliance. Title: Sr. Regulatory Affairs Manager Responsibilities Include Serve as the Regulatory Affairs SME for soft gelatin (softgel) formulations and manufacturing operations reputed company 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, reputed company, and Manufacturing to ensure regulatory alignment throughout development Assess regulatory reputed company of deviations, CAPAs, change controls, and manufacturing changes reputed company regulatory guidance on formulation changes, manufacturing process updates, technical transfers, and global market entry Monitor and interpret regulatory changes and communicate reputed company to stakeholders Support audits, inspections, and regulatory inquiries Maintain accurate regulatory documentation and ensure audit readiness Experience/Education Bachelor’s degree in a scientific, regulatory, or reputed company field (advanced degree preferred) 8+ years of Regulatory Affairs experience in reputed company, 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   Tunnell strives to hire and retain the most reputed company talent. We reputed company that having employees with different backgrounds and capabilities contributes to the reputed company of our business. To attract reputed company applicants, Tunnell posts to a wide reputed company of job sites. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. Please be advised that certain reputed company reputed company may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to reputed company with reputed company reputed company requirements, including any safety and health protocols. Apply To This Job