AxoGen
Sr. Regulatory Affairs Specialist (Global Labeling Lead)
AxoGen, Alachua, Florida, United States, 32615
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 Sr. Regulatory Affairs Specialist (Global Labeling Lead)
The Sr. Regulatory Affairs Specialist (Global Labeling Lead) provides strategic and operational leadership in labeling development and lifecycle management for the company's portfolio of nerve repair products. Reporting to the Director of Regulatory Affairs, this role owns the Company Core Data Sheet (CCDS), leads the Labeling Development Process initiative, and coordinates the preparation of FDA labeling communications under the leadership of the Vice President of Regulatory Affairs.
The Specialist will collaborate with Regulatory, Clinical, Safety, Medical Affairs, Commercial, and external consultants to ensure high-quality, globally compliant labeling and submission documentation. This role requires attention to detail, regulatory insight, and strong project management capabilities.
Requirements of the Sr. Regulatory Affairs Specialist (Global Labeling Lead)
Bachelor's degree in a scientific or regulatory discipline required; advanced degree preferred. Minimum 3 years of experience in Regulatory Affairs with 1+ years focused on labeling or regulatory document management. Experience preparing labeling documents for FDA and global health authorities. Prior experience in a regulated (biologic, device, or drug) industry preferred. Responsibilities of the Sr. Regulatory Affairs Specialist (Global Labeling Lead)
The specific duties of the Sr. Regulatory Affairs Specialist (Global Labeling Lead) include but are not limited to:
Serve as the Global Labeling Lead, managing end-to-end labeling strategy and execution across U.S. and international markets. Own and maintain the Company Core Data Sheet (CCDS), ensuring alignment with scientific data, safety updates, and regulatory precedent. Lead and facilitate cross-functional alignment on labeling content through collaboration with Regulatory Affairs, Clinical, Safety, Medical Affairs, and Commercial functions. Coordinate the preparation of FDA labeling-related Information Requests (IRs) and correspondence in support of communications led by the VP of Regulatory Affairs. Serve as the project lead for Axogen's Labeling Development Process, including implementation, training, governance, and continuous improvement. Author and manage internal review of U.S. labeling documents, including USPI, IFUs, and packaging/labeling content. Support development and maintenance of global labeling content for regulatory submissions in Canada, EU, UK, Australia, and other key markets. Lead scenario planning and competitive landscape analysis to inform global labeling strategy. Participate in or support labeling negotiation discussions with global health authorities in collaboration with senior regulatory leadership. Track implementation and version control of approved labeling changes. Ensure labeling documents meet all applicable regulatory requirements and industry guidelines. Format, QC, and publish submission-ready labeling documents using Veeva Vault RIM and in coordination with external partners. Maintain audit-ready regulatory files and support SOP development related to labeling and submission operations. 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
#LI-AC1
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
$89,604-$112,006 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.
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 Sr. Regulatory Affairs Specialist (Global Labeling Lead)
The Sr. Regulatory Affairs Specialist (Global Labeling Lead) provides strategic and operational leadership in labeling development and lifecycle management for the company's portfolio of nerve repair products. Reporting to the Director of Regulatory Affairs, this role owns the Company Core Data Sheet (CCDS), leads the Labeling Development Process initiative, and coordinates the preparation of FDA labeling communications under the leadership of the Vice President of Regulatory Affairs.
The Specialist will collaborate with Regulatory, Clinical, Safety, Medical Affairs, Commercial, and external consultants to ensure high-quality, globally compliant labeling and submission documentation. This role requires attention to detail, regulatory insight, and strong project management capabilities.
Requirements of the Sr. Regulatory Affairs Specialist (Global Labeling Lead)
Bachelor's degree in a scientific or regulatory discipline required; advanced degree preferred. Minimum 3 years of experience in Regulatory Affairs with 1+ years focused on labeling or regulatory document management. Experience preparing labeling documents for FDA and global health authorities. Prior experience in a regulated (biologic, device, or drug) industry preferred. Responsibilities of the Sr. Regulatory Affairs Specialist (Global Labeling Lead)
The specific duties of the Sr. Regulatory Affairs Specialist (Global Labeling Lead) include but are not limited to:
Serve as the Global Labeling Lead, managing end-to-end labeling strategy and execution across U.S. and international markets. Own and maintain the Company Core Data Sheet (CCDS), ensuring alignment with scientific data, safety updates, and regulatory precedent. Lead and facilitate cross-functional alignment on labeling content through collaboration with Regulatory Affairs, Clinical, Safety, Medical Affairs, and Commercial functions. Coordinate the preparation of FDA labeling-related Information Requests (IRs) and correspondence in support of communications led by the VP of Regulatory Affairs. Serve as the project lead for Axogen's Labeling Development Process, including implementation, training, governance, and continuous improvement. Author and manage internal review of U.S. labeling documents, including USPI, IFUs, and packaging/labeling content. Support development and maintenance of global labeling content for regulatory submissions in Canada, EU, UK, Australia, and other key markets. Lead scenario planning and competitive landscape analysis to inform global labeling strategy. Participate in or support labeling negotiation discussions with global health authorities in collaboration with senior regulatory leadership. Track implementation and version control of approved labeling changes. Ensure labeling documents meet all applicable regulatory requirements and industry guidelines. Format, QC, and publish submission-ready labeling documents using Veeva Vault RIM and in coordination with external partners. Maintain audit-ready regulatory files and support SOP development related to labeling and submission operations. 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
#LI-AC1
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
$89,604-$112,006 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.