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axogen · 4 days ago

Regulatory Affairs Manager (Clinical Focus)

Tampa, FL

Full-time

Onsite

Mid, Senior Level

$111K/yr - $138K/yr

4+ years exp

Axogen is committed to restoring health and improving the quality of life through innovative solutions in peripheral nerve function. The Regulatory Affairs Manager (Clinical Focus) will lead the development and implementation of regulatory strategies for clinical programs, ensuring compliance with applicable regulations and guiding cross-functional teams in regulatory submissions.

BiotechnologyMedicalMedical Device

Culture & Values

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

Regulatory AffairsRegulatory WritingClinical Programs21 CFR ComplianceProject ManagementStrategic Problem-SolvingBiologics ExperienceCombination ProductsDevice EnvironmentLeadership ExperienceTeam Leadership

Required

Bachelor's degree required; in a scientific, regulatory, or health-related discipline preferred

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%