Regulatory Affairs Manager

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

Job Summary of the Regulatory Affairs Manager

The Regulatory Affairs Manager will provide direction, leadership, and regulatory oversight in the development and implementation of domestic and international regulatory strategies and processes to assure the timely global commercialization of products 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 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 asset services team, the Manager 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 for assigned asset(s).  Responsible to assist in the preparation of departmental and project budgets as well as vendor management for services outsourced by the regulatory department relevant to assigned asset(s). 

Requirements of the Regulatory Affairs Manager

• A degree-level qualification in a relevant life sciences discipline; RAC or comparable regulatory credential preferred
• Five or more years’ experience in regulatory affairs with matrixed management responsibilities preferred
• Previous experience with IND/CTAs and Drug/Biologics Pathways preferred
• 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, Teams, and Excel)
• 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)
• 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.
• Fluency in English
• Ability to travel approximately 20%

Responsibilities of the Regulatory Affairs Manager

The specific duties of the Regulatory Affairs Manager 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 i.e. lead candidate selection through post-marketing to include development of target product profile, regulatory pathway, and product designations, planning, authoring, reviewing, coordination, and marketing authorization activities through post-market surveillance and change management activities.
• Regulatory Affairs Point of Contact (POC) for the Regulatory Authority for assigned asset(s). Negotiate and interact with regulatory (domestic and international) authorities during the development, review, in stages 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.
• Prepare or maintain technical files as necessary to obtain and sustain product approval/clearance
• Provide regulatory oversight for assigned assets and the regulatory maintenance of marketed products in-scope of the assigned asset. Ensuring reporting compliance through timely, appropriate, and accurate assessments (including assessments of change) regarding product surveillance, pharmacovigilance, product complaint handling, medical device reports (MDRs), adverse events, and field actions (recalls, corrections, removals). Responsible for AE, MAUDE, and periodic safety report filings as appropriate for the asset and filing of adverse event notifications to domestic and international Regulatory Authorities.
• Management of regulatory activities associated with development programs for the assigned asset including tracking the status of regulatory submissions and project assignments, providing status updates, and other communications to Sr. Leadership and consumers of regulatory information.
• Manage processes involved with maintaining annual licenses, registrations, listings, and patent information
• Provide guidance to multidisciplinary teams on the content, format, style and architecture of Clinical Trial Authorizations (IND/IMPD/CTAs) for Domestic and ex-US/ex-EU studies. Provide regulatory submission requirements and submission plan for US, ex-US, and ex-EU.
• 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.
• Manage processes involved with maintaining annual licenses, registrations, and FURLs including establishment and device listings as appropriate.
• Perform regulatory intelligence for information, guidance, and standards 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 Regulatory Authority Inspections or Audits when necessary
• Communicate options and recommend solutions to a wide range of difficult problems. Foster collaboration with Sales, Marketing, and Clinical to develop effective global launch plans.
• Provide continuing regulatory education and dissemination of regulatory information to the Research and Development teams, Operations team, Marketing, and Clinical teams.

Location

111 West Oak Ave., Tampa, FL  33602

OR

1363 Progress Blvd., Alachua, FL 32615

OR

913 Industrial Drive Pl., Vandalia, OH 45377

Compensation

The anticipated base wage or salary range for this position is $104,236 - $130,295.

The anticipated range for target compensation in the form of an annual bonus of 15% of base. 

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays 2 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, Equity, and Disability insurance, as described in more detail in summary plan descriptions.

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Salary : $104,236 - $130,295