Regulatory Affairs Manager (Global Labeling Lead)

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 (Global Labeling Lead)

The Regulatory Affairs Manager (Global Labeling Lead) provides strategic and operational leadership for the development, governance, and lifecycle management of labeling across Axogen’s global portfolio of nerve repair products. Reporting to the Director of Regulatory Affairs, this role serves as the Company’s authority on core scientific and regulatory labeling content, overseeing the U.S. Prescribing Information (USPI), Instructions for Use (IFUs), package/labeling content, and the Company’s Important Safety Information (ISI).
The Manager leads Axogen’s Labeling Development Process and labeling policy framework, ensuring global consistency, compliance, and inspection readiness. This role is accountable for cross-functional alignment on labeling strategy, content, and implementation, and drives change management when new safety or clinical information requires updates. The Manager partners closely with senior Regulatory leadership, including the Vice President of Regulatory Affairs, to support FDA labeling negotiations, as well as health authority discussions globally. This position requires strong leadership, cross-functional influence, and the ability to anticipate and resolve complex regulatory and labeling challenges.

Requirements of the Regulatory Affairs Manager (Global Labeling Lead)

• Bachelor’s degree required; in a scientific, regulatory, or health-related discipline preferred; advanced degree preferred.

• Minimum 4 years of experience in Regulatory Affairs, with at least 2 years focused on labeling or regulatory document management.

• Demonstrated leadership experience (cross-functional team leadership).

• Proven expertise in developing, negotiating, and maintaining labeling for FDA and global health authority submissions.

• Prior experience in a regulated biologic, combination product, or device environment strongly preferred.

• Strong project management and strategic problem-solving skills; ability to manage multiple priorities in a fast-paced environment.

Responsibilities of the Regulatory Affairs Manager (Global Labeling Lead)

The specific duties of the Regulatory Affairs Manager (Global Labeling Lead) include but are not limited to:

• Serve as Global Labeling Lead with accountability for end-to-end strategy, governance, and execution of labeling across U.S. and international markets.

• Own and maintain the USPI, IFUs, package labeling, and ISI, ensuring consistency across geographies, scientific accuracy, and compliance with regulatory precedent.

• Develop, maintain, and govern Axogen’s Important Safety Information (ISI), ensuring alignment with the USPI, IFUs, and package labeling. Coordinate updates with Regulatory, Safety, and Clinical functions and provide governance for ISI use in non-promotional contexts.

• Lead health authority negotiations on labeling content in collaboration with the Vice President of Regulatory Affairs and other senior leadership.

• Direct the Labeling Development Process, including governance, training, metrics, and continuous improvement, ensuring global alignment and operational excellence.

• Chair cross-functional labeling working groups to drive consensus among Regulatory, Clinical, Safety, Medical Affairs, and Commercial stakeholders.

• Oversee U.S. labeling documents through authorship, review, and submission, including responses to FDA Information Requests (IRs) and post-approval lifecycle updates.

• Lead development and maintenance of global labeling content for submissions in Canada, EU, UK, Australia, and other priority markets, ensuring integration with regional regulatory strategies.

• Labeling Policy and SOP Ownership: Lead or co-lead SOP development for labeling governance and life cycle management.

• Cross-functional Change Management: Lead impact assessments when new safety or clinical information may trigger global labeling updates.

• Supervise labeling operations at a governance level, ensuring effective version control, implementation planning, and inspection readiness in coordination with Regulatory Operations.

• Mentor and provide leadership to junior staff and cross-functional partners involved in labeling activities.

• Ensure compliance with applicable regulatory requirements for labeling content and processes.

• Perform other responsibilities as required to support the overall success of the Regulatory Affairs function and Axogen’s mission.

Location

111 West Oak Ave., Tampa, FL 33602

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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.