Job Summary of the VP, Regulatory Affairs Consistent with Axogen's mission and business purpose, as a member of the Executive Team, the Vice President, Regulatory Affairs (VP, RA) will report directly to the Chief Executive Officer of Axogen. The VP, RA is responsible for development and execution of the domestic and international regulatory strategies required for attainment of company objectives related to new product or therapy development, new product or therapy market approval, market development, and any other activity dependent on regulatory insight and leadership. As the leader of Axogen's regulatory affairs, the VP, RA is likewise responsible for maintenance of Axogen product registrations, licenses, accreditations and in general all related interactions and relationships with regulatory agencies and associated stakeholders. Additionally, the VP, RA will be responsible for working on development of regulatory policy with external groups such as Alliance for Regenerative Medicine (ARM), American Association of Tissue Banks (AATB) and others.
Requirements of the VP, Regulatory Affairs Bachelors' degree required; Masters' degree and/or Doctorate preferred. At least 15 years of progressive experience in a regenerative medicine, medical device, or pharmaceutical company with biologic experience a preferred capability. At least 5 years of experience in a leadership Regulatory Affairs position having direct reports. Professional experience and accomplishments will ideally include Biologics License Application (BLA) approvals and management. Alternatively, New Drug Application (NDA) or the Medical Device Class III level product or therapy approvals and management. Proven ability to develop relationships with the Center for Drug Evaluation and Research (CDER) of the FDA and/or the Center for Devices and Radiological Health (CDRH). Responsibilities of the VP, Regulatory Affairs The specific duties of the VP, Regulatory Affairs include but are not limited to:
Acts as the "Authorized" Regulatory Affairs representative to external regulatory agencies and industry groups. Directs, controls, and implements regulatory activities in accordance with Axogen specifications, FDA, EU, and other relevant international authorities and regulations. Develops and manages regulatory strategy that contemplates and addresses when required the interdependencies between mission, objectives, strategy, structure, people, and process. Cultivates and maintains Axogen involvement in external groups such as Alliance for Regenerative Medicine (ARM) and American Association of Tissue Banks (AATB) to help shape regulatory policies, including participation in working groups/committees with FDA and other international regulatory agencies. Prepares and/or oversees FDA and International submissions which could include, among others, IDEs, INDs, PMAs, 510(k)s, Biologic License Applications (BLA), International Technical Files, Design Dossiers, product registrations, MDRs, Vigilance Reporting and Canadian reporting requirements and associated follow-up reports. Manages outside consultants when required. Participates, partners, and/or provides support for colleagues and product teams on regulatory matters. Leverages effective relationships with regulatory agency contacts to proactively facilitate optimal regulatory outcome. Provides expert regulatory counsel on content and format, planning and managing regulatory activities throughout the product lifecycle. Analyzes and makes recommendations for improving regulations and guidelines. Communicates with US and international regulatory agencies. Develops and maintains current regulatory knowledge and ensures that staff is aware of new and existing relevant procedures, guidance, and regulations. General activities and competencies will include: Competent presentation and written and verbal communications skills with team, peers, executive management, and/or board of directors. Demonstrate strong analytical thinking and organizational skills. Ensure by example and via formal expectations the RA team provides actionable feedback across all organizational levels, in support of mission objective achievement. Establish and manage the department budget cost-efficiently while always maintaining effectiveness. Develop, as necessary, company policies and procedures, and by example, compliance to company policies and procedures. Develop agreements and contracts in compliance with company procedures. Collaborate with diverse stakeholders and build strong, collaborative relationships; manage competing agendas and priorities across different functional departments. Set direction and focus through the planning and a regular performance review process and oversee staff development based on organizational objectives and performance management. Demonstrate cross-functional expertise in complex environments. Perform other related duties as assigned by supervisor. Location 111 West Oak Ave., Tampa, FL 33602
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