Axogen
Director, Regulatory Affairs
Axogen, Alachua, Florida, United States, 32615
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
Benefits/Compensation
#J-18808-Ljbffr
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
Benefits/Compensation
#J-18808-Ljbffr