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
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