Regulatory Affairs Manager, Ad Promo Review (Professional Education Focus)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 youll love working atAxogen:
- Friendly openandfunteam culturethat values uniqueperspectives
- Company-wide dedicationto profoundly impacting patients lives
- Comprehensive high-quality benefitspackage effective on date of hire
- Educationalassistanceavailable for all employees
- Matching 401(k)retirementplan
- Paid holidaysincluding floating holidaysto 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)
- Bachelors 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.
- 12 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/dont 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
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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 as described in more detail in summary plan descriptions.
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.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Nerve repair has evolved. See what Axogen’s contemporary nerve repair solutions can do for you.
