Job Summary of the Sr. Regulatory Affairs Specialist 

• Reporting to the VP, Regulatory, a core focus of the Sr. Regulatory Affairs 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.
• 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 inspections.
• Reviews change controls, deviations and other quality records for impact to regulatory status of commercial products.
• 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 preferred, 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 in 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.
• 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

913 Industrial Drive Place, Vandalia, OH  45377

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Benefits/Compensation