Regulatory Affairs Manager (Clinical Focus)

Axogen•Alachua, FL

13d•$110,585 - $138,231

About The Position

Reporting to the Sr. Manager, Regulatory Affairs, the manager will provide direction and leadership in the development and implementation of domestic and international regulatory strategies and processes for Axogen’s clinical programs in compliance with applicable regulations, recommended guidance, and standards. The manager will provide support to regulatory submissions, regulatory activities, cross-functional teams, and supervise the preparation of regulatory deliverables to support clinical programs in domestic and international markets. The manager is accountable for cross-functional alignment relating to clinical regulatory strategy and deliverables. The manager will review information related to safety for Axogen’s product portfolio and perform corresponding regulatory assessments. The manager will perform clinical-focused regulatory intelligence activities related to the markets in which clinical programs are being considered or are in effect. The manager will be responsible for the management of Regulatory Specialist(s) and Interns. The manager will assist in or direct interactions with regulatory bodies and participate in regulatory inspections.

Requirements

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
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.
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%

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.