axogen
Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)
axogen, Florida, New York, United States
Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)
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 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 FDA CBER/APLB expectations for 351 HCT/P (biologic) products.
This role may be performed remotely within the Eastern time zone of the United States.
Requirements
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 Professional Education/seminar content (preferred but not required).
Working knowledge of CBER/APLB requirements for promotional and educational materials.
Familiarity with Veeva PromoMats for review and export of 2253 packages; proficiency in Microsoft Office 365 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 The specific duties of the Regulatory Affairs Manager include but are not limited to:
Regulatory Review – Professional Education (Primary):
Review HCP education materials (slide decks, speaker notes, faculty training content, invitations, agendas, registration pages, handouts, post‑event follow‑ups, 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; elevate complex or high‑risk issues as appropriate.
Form FDA 2253 Preparation & Handoff:
Prepare and export Form FDA 2253 packages from PromoMats and handoff to Regulatory Operations for submission to FDA CBER/APLB.
Support Regulatory Operations with follow‑up questions and ensure consistency of exported materials.
Cross‑Functional Collaboration & Meetings:
Participate in Medical, Legal, & Regulatory (MLR)/Promotional Review Committee discussions, aligning with Medical and Legal on recurring claims, FAQs, and event timelines (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 This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance.
Salary Range: $110,585—$138,231 USD
#J-18808-Ljbffr
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 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 FDA CBER/APLB expectations for 351 HCT/P (biologic) products.
This role may be performed remotely within the Eastern time zone of the United States.
Requirements
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 Professional Education/seminar content (preferred but not required).
Working knowledge of CBER/APLB requirements for promotional and educational materials.
Familiarity with Veeva PromoMats for review and export of 2253 packages; proficiency in Microsoft Office 365 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 The specific duties of the Regulatory Affairs Manager include but are not limited to:
Regulatory Review – Professional Education (Primary):
Review HCP education materials (slide decks, speaker notes, faculty training content, invitations, agendas, registration pages, handouts, post‑event follow‑ups, 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; elevate complex or high‑risk issues as appropriate.
Form FDA 2253 Preparation & Handoff:
Prepare and export Form FDA 2253 packages from PromoMats and handoff to Regulatory Operations for submission to FDA CBER/APLB.
Support Regulatory Operations with follow‑up questions and ensure consistency of exported materials.
Cross‑Functional Collaboration & Meetings:
Participate in Medical, Legal, & Regulatory (MLR)/Promotional Review Committee discussions, aligning with Medical and Legal on recurring claims, FAQs, and event timelines (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 This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance.
Salary Range: $110,585—$138,231 USD
#J-18808-Ljbffr