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Regulatory Affairs SME

May 15, 2026

<div class="content-intro">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.</div>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 <ul> <li>Serve as the Regulatory Affairs SME for soft gelatin (softgel) formulations and manufacturing operations</li> <li>Develop and execute regulatory strategies to support product development, commercialization, and lifecycle management activities</li> <li>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</li> <li>Review and approve product labels, claims, and marketing materials for regulatory compliance</li> <li>Support product registrations, submissions, and ongoing lifecycle management activities</li> <li>Partner cross-functionally with R&D, Quality, and Manufacturing to ensure regulatory alignment throughout development</li> <li>Assess regulatory impact of deviations, CAPAs, change controls, and manufacturing changes</li> <li>Provide regulatory guidance on formulation changes, manufacturing process updates, technical transfers, and global market entry</li> <li>Monitor and interpret regulatory changes and communicate impact to stakeholders</li> <li>Support audits, inspections, and regulatory inquiries</li> <li>Maintain accurate regulatory documentation and ensure audit readiness</li> </ul> Experience/Education <ul> <li>Bachelor’s degree in a scientific, regulatory, or related field (advanced degree preferred)</li> <li>8+ years of Regulatory Affairs experience in pharma, biotech, or dietary supplements</li> <li>Strong expertise in soft gelatin (softgel) dosage forms required</li> <li>Deep knowledge of U.S. FDA regulations and relevant global requirements</li> <li>Experience with labeling, claims review, and compliance (supplements or OTC preferred)</li> <li>Familiarity with cGMP and manufacturing processes</li> <li>Proven ability to work cross-functionally and influence stakeholders</li> <li>Strong communication, analytical, and problem-solving skills</li> </ul> <div class="content-conclusion">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.</div>

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DISCLAIMER

Get Hired Faster With COMPANY_NAME!

1: COMPANY_NAME Smart Tools and Direct Employer Connections Help Speed Up Your Hiring Process

2: With Better Matches, Real-time Job Alerts, and Direct Employer Responses, COMPANY_NAME Helps Many Candidates Secure Interviews and Job Offers Within 15 to 30 Days!

3: The Type of Resume You Need to Get Priority Placement

4: Browse Full-Time, Part-Time, and Freelancing Roles With COMPANY_NAME

5: COMPANY_NAME Helps You Grow Your Career

6: The Easiest Way To Find A Job

7: Find Roles That Offer Growth, Culture & Benefits

8: Get Support With Resume, Interviews & Career Planning

9: Your Future Starts Today

10: Get Hired Within 15 to 30 Days With COMPANY_NAME

Regulatory Affairs SME

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

5. HOW DO YOU PROCESS INFORMATION?

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

8. HOW TO PRIORITIZE WORK?

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

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