Regulatory Affairs Manager, Advertising & Promotional Material Review Job at Axo

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, Advertising & Promotional Material Review

The Regulatory Affairs Manager (Advertising & Promotional Material Review) leads the end-to-end review process for promotional and non-promotional content across Axogen's portfolio of brands, with a specific focus on the Avance Nerve Graft® product line. This role is pivotal in ensuring strategic alignment, efficiency, and compliance of all advertising and promotional material while adhering to regulatory standards, company policies, and legal requirements.

The incumbent will ensure that all materials comply with Food and Drug Administration (FDA) requirements across:

• Center for Biologics Evaluation and Research (CBER)/ Office of Tissues and Advanced Therapies (OTAT), and Advertising and Promotional Labeling Branch (APLB) for our 351 HCT/P (biologic) product(s),
• CBER/OTAT (21 CFR Part 1271) for 361 HCT/P product(s), and
• Center for Devices and Radiological Health (CDRH) for our medical device products, while fostering a culture of collaboration and compliance.

The Manager will also participate with other Regulatory Affairs team members in cross-functional brand planning and provide strategic guidance on promotional campaigns. This role may be performed remotely within the Eastern time zone of the United States.

Requirements of the Regulatory Affairs Manager, Advertising & Promotional Material Review

• Bachelor's degree in a scientific, healthcare, or regulatory discipline preferred; advanced degree (PharmD, JD, MBA, MS) desirable. In lieu of a degree, equivalent years of directly relevant regulatory affairs or promotional review experience will be considered.
• 1-3 years in advertising and promotional review.
• Excellent oral and written communication skills.
• Must be proficient in MS Office 365 (with an emphasis on MS Word, Teams, and Excel).
• Experience with Veeva PromoMats, Adobe Acrobat and publishing-related plugins and viewers.
• Highly motivated and results-oriented leadership style.
• Ability to be flexible with changing priorities.
• Demonstrated leadership, strategic thinking, and cross-functional influence skills.
• Ability to travel approximately 10%.

Responsibilities of the Regulatory Affairs Manager, Advertising & Promotional Material Review

The specific duties of the Regulatory Affairs Manager, Advertising & Promotional Material Review include, but are not limited to:

• As a part of the Regulatory Affairs team, serves as the dedicated member to help to lead the regulatory review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with all regulatory requirements (CBER/APLB for 351 HCT/P biologics; CBER/OTAT 21 CFR Part 1271 for 361 HCT/P tissue products; and CDRH for medical devices) and alignment with business objectives.
• Oversee and ensure timely and compliant FDA submissions for 351 promotional materials (Form 2253, advisory comments, etc.) following Medical, Legal, and Regulatory (MLR) Committee. approval, with appropriate support from Regulatory Operations. For 361 tissue products (e.g., Avive+), ensure promotional compliance with Part 1271 (truthful, non-misleading, consistent with tissue framework). For medical devices, ensure compliance with CDRH promotional regulations and enforcement expectations.
• Serve as a Subject Matter Expert (SME) on Veeva PromoMats, providing technical guidance and best practices to colleagues regarding material submission and compliance.
• Manage regulatory reviews of materials within Veeva PromoMats, including coordinating input from other members of the Regulatory team.
• Assist in leading live MLR/PRC review meetings, providing regulatory input as a part of the broader Regulatory Affairs team, summarizing discussions, aligning stakeholders, and ensuring timely and compliant decision-making.
• Track and follow up on reviewer feedback, outstanding action items, and next steps to ensure timely resolution.
• Communicate material status updates to relevant stakeholders regularly.
• Serve as a strategic partner along with other members of the Regulatory Affairs team in brand planning and tactical execution meetings to anticipate upcoming review needs and ensure alignment with business objectives.
• Work with other members of the Regulatory Affairs team to continuously assess, enhance, and maintain the Ad Promo Review process and Standard Operating Procedures (SOPs) to improve efficiency, effectiveness, and compliance with regulatory guidelines.
• Work with other members of the Regulatory Affairs and Legal teams to train employees on the regulatory guidance for the promotional material review process.
• Work with other members of the cross-functional MLR team to identify bottlenecks and inefficiencies in the review workflow, streamlining operations, and minimizing material rejections.
• Work with other members of the cross-functional MLR team to track key performance indicators (KPIs) such as review turnaround times and submission quality, implementing improvements as needed.
• Participating in mentoring and coaching among Regulatory Affairs colleagues and cross-functional team members, sharing guidance on regulatory requirements and best practices for advertising and promotions.
• Serve as a compliance advocate as a part of the Regulatory Affairs team in review discussions, fostering solutions-oriented dialogue to enable Marketing and Sales objectives while ensuring adherence to FDA regulations and Axogen policies.
• Collaborate with cross-functional teams to identify and resolve any issues in the review process.
• Monitor regulatory enforcement trends across CBER/APLB (351), CBER/OTAT (361), and CDRH (devices), competitor actions, and evolving FDA expectations to inform Axogen's promotional strategy.
• Perform other duties and responsibilities as requested or assigned to support the overall success of the team and the business.

Location

111 West Oak Ave., Tampa, FL 33602

OR

13631 Progress Blvd., Alachua, FL 32615

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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.

Salary Range

$110,585-$138,231 USD

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.