Regulatory Affairs SME

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence 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 lead regulatory strategy 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 North 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 all applicable requirements for dietary supplements, OTC, or pharmaceutical products, with a strong focus 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 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 Experience/Education Bachelor’s degree in a scientific, regulatory, or related field (advanced degree preferred) 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 Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols. Apply To This Job