Regulatory Affairs Manager, Ad Promo Review

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)

The Regulatory Affairs Manager (Ad Promo Review – Professional Education Focus) performs advertising and promotional (ad promo) regulatory reviews with a primary emphasis on Professional Education seminar content (live, virtual, and enduring). The Manager partners with Professional Education, Medical, Legal, and Marketing to ensure materials are accurate, balanced, consistent with current labeling, and aligned with Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)/Advertising and Promotional Labeling Branch (APLB) expectations for 351 HCT/P (biologic) products. The role also considers requirements applicable to CBER/ Office of Tissues and Advanced Therapies (OTAT) (21 CFR Part 1271) for 361 tissue products and Center for Devices and Radiological Health (CDRH) for medical devices, as relevant to specific materials.

This role may be performed remotely within the Eastern time zone of the United States.

Requirements of the Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)

• Bachelor's degree in a scientific, healthcare, communications, or regulatory discipline preferred; advanced degree (MS, PharmD, PhD, JD) desirable. Equivalent relevant experience considered in lieu of degree.
• 1–2 years of advertising and promotional regulatory review experience in pharma/biotech (required).
• Experience directly reviewing Health Care Provider (HCP) Professional Education/seminar content (preferred but not required).
• Working knowledge of CBER/APLB requirements for promotional and educational materials (e.g., fair balance, consistency with labeling, substantiation; scientific exchange vs. promotion).
• Familiarity with Veeva PromoMats for review and export of 2253 packages; proficiency in MS Office 365 (Word, Teams, Excel) and Adobe Acrobat.
• Excellent oral/written communication, redlining, and annotation skills; ability to interpret clinical/scientific data and translate into compliant claims/visuals.
• Strong organizational skills with the ability to manage multiple deadlines and shifting priorities; collaborative, solutions-oriented working style.
• Ability to travel approximately 10%-20%.

Responsibilities of the Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)

The specific duties of the Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus) include but are not limited to:

• Regulatory Review – Professional Education (Primary):
• Review HCP education materials (e.g., slide decks, speaker notes, faculty training content, invitations, agendas, registration pages, handouts, post-event follow-ups, and enduring/on-demand content) for compliance with labeling, balance, and substantiation standards.
• Distinguish scientific exchange/education from promotion; advise on appropriate context, disclosures, and disclaimers to align with APLB expectations.
• Provide clear, actionable comments/redlines and risk-ranked recommendations; escalate complex or high-risk issues as appropriate.
• Form FDA 2253 Preparation & Handoff:
• Prepare and export Form FDA 2253 packages from PromoMats (and associated artifacts) and handoff to Regulatory Operations for submission to FDA (CBER/APLB).
• Support Regulatory Operations with follow-up questions and ensure completeness/consistency of exported materials.
• Cross-Functional Collaboration & Meetings:
• Participate in Medical, Legal, & Regulatory (MLR)/Promotional Review Committee (PRC) discussions, aligning with Medical and Legal on recurring claims, FAQs, and event timelines (e.g., congress symposia, speaker trainings).
• Coordinate review timing with Professional Education for seminar series, faculty onboarding, and content refresh cycles.
• Guidance, Templates, and Enablement:
• Contribute to creation and maintenance of checklists, guidance notes, and pre-approved claims/templates to streamline Professional Education content development and reduce rework.
• Provide practical coaching to stakeholders on "do/don't" guidance and evidence standards.
• Monitoring & Continuous Improvement:
• Monitor APLB/CBER enforcement trends and competitor actions relevant to HCP education; share insights with the team.
• Identify drivers of rework and collaborate with cross-functional partners to improve cycle times and consistency.
• Broader Support:
• May be asked to provide ad promo review for other promotional materials beyond Professional Education (e.g., HCP/consumer digital, web, social, sales aids, congress materials) based on business needs.
• Perform other duties and responsibilities as requested or assigned to support the overall success of the team and the business.

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL 33602

OR

Remote

Benefits/Compensation

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.