Job Description
The Sr. Regulatory Affairs Specialist will provide regulatory review and lifecycle support for advertising, promotional, labeling, packaging, digital, and other external-facing materials. This role evaluates claims, messaging, and content for compliance, accuracy, and alignment with regulatory requirements while guiding cross-functional teams and identifying risks.
Key Responsibilities:
- Review advertising, promotional, labeling, packaging, and digital materials for regulatory compliance and accuracy
- Evaluate claims, benefit statements, and product positioning for substantiation and regulatory impact
- Provide clear regulatory guidance and recommendations to cross-functional teams (Marketing, Medical, Legal, Quality, Operations, etc.)
- Coordinate regulatory review processes, consolidate feedback, and manage timelines and trackers
- Prepare and maintain documentation including approvals, submissions, and regulatory records
- Monitor regulatory trends, guidance, and enforcement updates and communicate implications to stakeholders
- Support audits, inspections, and health authority requests
- Identify compliance risks, documentation gaps, and process improvement opportunities
- Exercise independent judgment and escalate complex or high-risk issues as needed
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
- Bachelor’s degree in science, nutrition, regulatory affairs, or related field required (advanced degree preferred)
- 6–9 years of Regulatory Affairs experience in a regulated industry
- Experience with advertising/promotional review, labeling, product claims, and regulatory compliance
- Working knowledge of FDA and FTC regulations related to labeling, advertising, and substantiation
- Experience evaluating regulatory impact, claim support, and labeling changes
- Experience coordinating cross-functional reviews and managing regulatory workflows
- Familiarity with document management or regulatory systems preferred
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.