Regulatory Affairs Manager Job Description
This position involves overseeing the development and implementation of regulatory strategies to ensure compliance with relevant laws and regulations.
* Main Responsibilities:
* Developing and monitoring the evolution of product health claims from initial development to commercialization and postlaunch monitoring.
* Serving as the internal subject-matter expert on regulatory requirements for new product launches, reformulations, and label updates.
* Driving regulatory priorities through clear project plans, progress tracking, and status reporting to senior stakeholders.
* Supporting preparation and management of regulatory submissions.
* Authoring and maintaining technical dossiers, claim-support packages, and global regulatory filings with precision and clarity.
* Reviewing, monitoring, and revising marketing copy on all advertisements made on products to ensure that marketing claims align with clinical science and adhere to relevant regulatory guidance.
* Working closely with marketing on artwork development and approval to ensure product claims are compliant with relevant regulatory guidelines.
* Monitoring priorities, tracking progress against schedules, and communicating status updates to other departments.
* Ensuring health claim compliance with final products and relevant regulatory requirements for different jurisdictions.
* Supporting Regulatory in creating submissions and responding to submission inquiries.
* Authoring technical and regulatory documents with clarity, detail, and correctness.
Required Skills and Qualifications
* Essential Qualifications:
* 5+ years of U.S. dietary supplement regulatory affairs experience, preferably within an established supplement brand.
* Bachelor's degree in Biology or equivalent, with a Master's or Ph.D. preferred or RA certification (e.g., RAPS RAC).
* Deep experience with FDA guidance documents, FTC documents, and global supplement regulatory frameworks.
* Proven record managing health-claim development, label reviews, and regulatory submissions.
* Excellent written and verbal communication skills, with the ability to translate technical science into actionable marketing guidance.
* Strong project management skills, including cross-functional leadership and stakeholder communication.
Benefits
* Fully remote working with home office setup.
* Annual performance-related bonus.
* Employee ownership.
* 401(k) plan with matching.
* Diverse health benefits covering medical, dental, and vision.
* Dedicated budget for team events.