axogen · 10 hours ago
Regulatory Affairs Manager (Clinical Focus)
Alachua, FL
Full-time
Onsite
Mid, Senior Level
$114K/yr - $142K/yr
4+ years expAxogen is a company dedicated to restoring health and improving quality of life through innovative solutions for peripheral nerve function. The Regulatory Affairs Manager (Clinical Focus) will lead the development and implementation of regulatory strategies for clinical programs, ensuring compliance with regulations and overseeing regulatory submissions and activities.
BiotechnologyMedicalMedical Device
Responsibilities
Acts as the Regulatory-Clinical representative on cross-functional clinical development teams to ensure regulatory requirements, recommended guidance and applicable standards are incorporated into the development process and continued compliance is maintained
Provides regulatory oversight for assigned projects, focused on clinical development programs and the regulatory maintenance of active trials
Participates in clinical risk-benefit analysis, providing input and a regulatory perspective regarding risk assessment
Keeps Senior Management informed of the regulatory status of products’ clinical programs and significant regulatory issues and provides updates regarding new developments
Leads and drives submission activities (planning, authoring, reviewing, coordination, compilation, submission) for assigned projects in both investigational and post-marketing lifecycle phases
Coordinates with Regulatory Operations on the submission management of clinical amendments and supplements to applications, inclusive of providing guidance on correct eCTD locations and document lifecycle phases for submission content
Creates and manages Clinical Study records in Vault RIM
Coordinates with Clinical Sciences and Operations, Medical Affairs, and Pharmacovigilance representatives on the creation and maintenance of documentation maintained within investigational applications, e.g. clinical efficacy and safety sections, investigator’s brochure, protocols, and risk-related documentation
Coordinates with Clinical representatives on processes and regulatory requirements for maintaining public records of clinical trials (such as clinicaltrials.gov)
Assesses information related to safety in coordination with Axogen’s Pharmacovigilance group for reportability requirements across applicable markets
Maintain and improve practices, standard operating procedures (SOPs), metrics, work instructions, reports, and forms, keeping with current regulatory requirements and best practices
Provide department support during FDA (BIMO), and other external or internal audits
Provide continuing regulatory education and dissemination of regulatory information to the clinical, development, and pharmacovigilance groups, as well as other groups as necessary
Qualification
Required
Minimum 4 years of experience in Regulatory Affairs, with at least 1 year focused on clinical programs
Demonstrated leadership experience (cross-functional team leadership)
Experience in regulatory writing and submitting successful regulatory submissions in both domestic and international markets
Strong project management and strategic problem-solving skills; ability to manage multiple priorities in a fast-paced environment
Comprehensive knowledge relating to 21 CFR 210, 211, 312, 314, 600, 601, Current Good Clinical Practices (cGCPs), and ICH efficacy and safety guidelines
Ability to travel approximately 20%
Preferred
Bachelor's degree required; in a scientific, regulatory, or health-related discipline preferred
Prior experience in a regulated biologic, combination product, or device environment strongly preferred
Benefits
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
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$255.92MKey Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
legacy.thefly.com
2026-01-23
BioWorld Financial Watch
2026-01-23
2026-01-22
Company data provided by crunchbase