Director, Regulatory Affairs
Axogen, Inc.

Job Info

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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Flexible working hours
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Director, Regulatory Affairs

Reporting to the VP, Regulatory, a core focus of the Director, RA is to author high-quality regulatory documents, including Chemistry, Manufacturing, and Controls (CMC) summaries, clinical summaries, and other sections of the Electronic Common Technical Document (eCTD) required to support Axogen's regulatory dossiers. A breadth of regulatory pathway and phase of dossiers are provided to the Regulatory Authorities to include peri-approval through commercialization (INDs/CTAs, BLAs, 510Ks, PSPs etc.) as well as post marketing (clinical and CMC supplements/variations and periodic reporting requirements) in both the US and internationally.

Requirements of the Director, Regulatory Affairs

• Minimum of Bachelor's degree; MS or PhD preferred.
• A minimum of 10 years' experience in a regulatory affairs or related role in the biologics or pharmaceutical industry is required.
• Minimum 5 years of people management.
• Knowledge of Tissue, Biologics, Pharmaceutical and Medical domestic and OUS regulations.
• Knowledge of ICH's eCTD/eCTD EU specifications.
• Demonstrated ability to effectively communicate both verbally and in writing.
• Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
• RAPS Regulatory Affairs Certification (RAC) preferred.
• Ability to be flexible with changing priorities.
• Ability to travel approximately 20%.
• Excellent oral and written communication skills.
• Excellent interpersonal and team-building skills.

Responsibilities of the Director, Regulatory Affairs

The specific duties of the Director, Regulatory Affairs include but are not limited to:

• Lead team of RA professionals.
• With appropriate guidance from the VP, RA and internal technical SMEs, the Director, RA will oversee and assist in the preparation of regulatory documentation that is consistent with regulatory requirements. Verifies quality, completeness, and accuracy of information. Acts as an intradepartmental and interdepartmental liaison when necessary to ensure all regulatory document deliverables with direct reports are processed and compiled in alignment with timelines.
• As a member of the Regulatory Team, the Director, RA is responsible for understanding, compiling, and maintaining regulatory information/databases or systems, including creating and maintaining Biologics, Device, and Tissue Product and Combination Product Dossiers and related reports including the generation of and/or assessment of product compliance reports.
• Manages direct reports including work schedules, work product and employee relations.
• Develops or conducts employee (intra and inter departmental) regulatory training.
• Assists in regulatory and compliance audits.
• Collaborates maintaining Risk Management files and quality system processes, such as design controls, change control, labeling, advertising, etc., to ensure regulatory compliance.
• Prepare, author, edit, compile, and review high-quality, clearly messaged documents founded in science and compliance with regulatory standards for submission to regulatory agencies and health authorities.
• Provide regulatory intelligence and act as Regulatory representative on a variety of corporate strategy and product development strategy.
• Maintain knowledge of biologics, pharmaceutical, device, and tissue regulations, guidance, and standards.
• Participation and collaboration activities in cross-functional projects including new product development, marketing, and design review activities including data analysis and comprehensive reviews to support the US or International regulatory submissions including regulatory pathway justifications, expanded indications, etc.
• Supports regulatory review of labels, labeling, and promotional materials to ensure compliance with domestic and international regulations.
• Collaborates with the development of regulatory training programs and procedures.
• Development and maintenance of departmental budgetary plans.
• Development and maintenance of departmental goals.
• Knowledge transfer and transition support to new team member(s).
• Other areas as assigned by Supervisor.

Location

111 West Oak Ave., Tampa, FL 33602

OR

13631 Progress Blvd., Alachua, FL 32615

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Benefits/Compensation

This position is eligible for an annual bonus. 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, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$159,135-$198,919 USD

Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us

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