Sr. Regulatory Affairs Specialist
Axogen, Inc.

Job Info

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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!

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 is hiring for a Sr. Regulatory Affairs Specialist in Tampa!

Job Summary of the Sr. Regulatory Affairs Specialist

• Reporting to the Regulatory Affairs Manager, a core focus of the Sr. Regulatory Specialist 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 periapproval 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.
• With appropriate guidance from the RA leads and internal technical SMEs, the RS will prepare, compile, and present data consistent with regulatory requirements. Verifies quality, completeness, and accuracy of information. Acts as an interdepartmental liaison when necessary to ensure all regulatory document deliverables are processed and compiled in alignment with timelines •
• As a member of the Regulatory Team, the RS 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.
• Develops or conducts employee 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.

Requirements of the Sr. Regulatory Affairs Specialist

• Bachelor's degree in Life Sciences, Engineering or English preferable, or in a related field commensurate with experience
• 3+ years of experience authoring and working with Biologics, Pharmaceutical, Device or Tissue regulatory submissions
• Knowledge of Biologics, Pharmaceutical and Device or Tissue regulations and Quality System regulation requirements (e.g., 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Part 210/211, 21 CFR Part 600, ISO 13485, ISO 9001, ISO 14971, AATB accreditation guidelines)
• 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
• Experience with application of risk management processes
• Ability to travel approximately 20%

Responsibilities of the Sr. Regulatory Affairs Specialist

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

• 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
• Lead document comment resolution for content issues and questions arising during the authoring process. Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents
• Perform data analysis and comprehensive literature reviews to support the US or International regulatory submissions including regulatory pathway justifications, expanded indications, etc.
• Collaborate with the preparation of International regulatory dossiers and submissions as the international market develops
• Maintain knowledge of biologics, pharmaceutical, device, and tissue regulations, guidance, and standards
• Participate in cross-functional projects including new product development, marketing, and design review activities
• Supports regulatory review of labels, labeling, and promotional materials
• Collaborates with the development of regulatory training programs and procedures
• Assist in complaint handling and analysis
• Maintain corporate regulatory files
• Comply with all company policies, procedures, and SOPs

Location

111 West Oak Ave., Tampa, FL 33602

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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

$86,994-$108,743 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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