Axogen is hiring for a Sr. Manager of Regulatory in Tampa, FL, Alachua, FL, or Vandalia, OH!

Job Summary of the Sr. Manager of Regulatory

The Sr. Manager, Regulatory will provide direction and leadership in the development and implementation of domestic and international regulatory strategies and processes to assure the timely global commercialization of products in the Axogen portfolio in compliance with applicable regulations and standards as a part of the regulatory asset management team. Working collaboratively in a cross-functional environment on a diverse range of topics that require in-depth Regulatory submission knowledge, understanding of industry trends, and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership. As a part of the regulatory strategic and centralized services team, the Sr. Manager, Regulatory will additionally provide direction and support to centralized submissions planning, lifecycle management solutions, and regulatory intelligence activities, and supervise the preparation and planning of regulatory deliverables to introduce new/ changed products to domestic and international markets. Responsible to assist in the preparation of departmental and project budgets as well as vendor management for services outsourced by the regulatory department.

Requirements of the Sr. Manager of Regulatory

• Bachelor's Degree in a scientific discipline; RAC or comparable regulatory credential preferred
  Seven or more years’ experience in regulatory affairs with direct project and matrixed management responsibilities
• Experience in writing and submitting successful regulatory submissions both domestic and international. Excellent oral and written communication skills
• Must be proficient in MS Office 365 (with an emphasis on MS Word)
• Experience with Adobe Acrobat and publishing-related plugins and viewers
• Strong knowledge of eDocument Management Systems (eDMS) and eCTD Publishing Systems and Regulatory Information Systems (VEEVA platforms, RIM preferred)
• Must have proven experience with electronic submissions, specifically eCTD and the use of Major Regulatory Authority Platforms/Gateways.
• Highly motivated, and results-oriented leadership style.
• Ability to be flexible with changing priorities.
• Ability to travel approximately 20%

Responsibilities of the Sr. Manager of Regulatory

The specific duties of the Sr. Manager of Regulatory include but are not limited to:

• Acts as a global regulatory lead to drive asset or portfolio-level global development and submission activities across the lifecycle including from lead candidate selection through post-marketing (development of target product profile, regulatory pathway and product designations, planning, authoring, reviewing, coordination, and submission activities).
• Provides regulatory reviews in the context of Medical, Legal, Regulatory (MLR) expectations, and technical regulatory advice to prepare pre-marketing and post-marketing submissions and ensure high-quality standards that meet expectations.
• Provide input on and regulatory de-risking reviews for specifications, process design controls, human factors study protocols, prescribing information (PI/PIL), instruction for use (IFU), artwork, and other labeling and marketing materials, etc. as the global Regulatory lead for the asset or program.
• Negotiate and interact with regulatory (domestic and international) authorities during the development, review, and peri-approval through marketing/pre-marketing applications (IND/CTA, NDA/BLA, PMA, 510K, RMAT/PRIME, PIP/PAS) procedures to ensure the necessary market authorization/clearance.
• Provides regulatory oversight for assigned assets and the regulatory maintenance of marketed products in-scope of the assigned assets. Ensuring reporting compliance through timely, appropriate and accurate assessments regarding pharmacovigilance, medical device reports (MDRs), adverse events, and field actions (recalls, corrections, removals). Responsible for Maude and other periodic safety report filings as appropriate for the asset and filing of adverse event notifications to international authorities. Strategic and Centralized Services: Planning, Leadership, and Communication
• Oversee the maintenance of policies, procedures and processes, templates, standards, and guide sheets for the Regulatory team. Proactively make recommendations and propose solutions for future development and improvements to ensure high quality and KPI effectiveness of the Regulatory group.
• Independently format, publish, transmit submissions or manage the relationship and coordination with appropriate vendors or regulatory affiliates for these services. Ensure regulatory file audit readiness including historical archives of all submissions and communication logs and templates
• Track the status of regulatory submissions and project assignments; provide status updates and other communications to Sr. Leadership and consumers of regulatory information. Manage timelines for submission calendar and regulatory project planning tools in MS Teams and other internal regulatory operation supporting tools/systems including KPI generation.
• Manage and coordinate marketing material review planners and associated MLR processes via MS Teams and support the development of future process improvements.
• Manage processes involved with maintaining annual licenses, registrations, and FURLs including establishment and device listings as appropriate.
• Perform regulatory intelligence for information pertinent to Axogen assets including our pipeline and provide a preliminary assessment of the impact of new or modified regulations and guidance. Identify and further develop contracts/services with vendors which support streamlining and advancing our Regulatory Intelligence capabilities.
• Support due diligence activities and audits when necessary
• Participate in related Core and Functional team meetings as needed and ensure adequate follow-up Regulatory Technical support
• Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs
• Troubleshoot complex system user issues
• Develop and maintain controls for user access and management of regulatory agency portal and systems
• Oversees matrix/project leadership, training, and guidance to junior team members
• Assist in regulatory department budget oversight and preparation

Location

1363 Progress Blvd., Alachua, FL

or

111 W. Oak Ave., Tampa, FL

or

913 Industrial Dr. Pl., Vandalia, OH

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Benefits/Compensation