Regulatory Affairs Subject Matter Expert

Summary

Job Description

Daily Responsibilities:

Help accelerate the development of lifesaving medical products for the Warfighter by serving as a regulatory expert at the forefront of military medical innovation. In this role, you will guide the regulatory strategy for drugs, biologics, medical devices, and other advanced medical solutions, working closely with scientists, clinicians, product managers, and government leaders. Your expertise will directly influence the successful development, approval, and fielding of critical capabilities that support military readiness and improve health outcomes.

• Provide specialized guidance and support and serve as a technical resource, offering in-depth expertise on relevant regulatory requirements, strategies, and processes to ensure successful product development, submission, and lifecycle management.
• Provide expert advice and guidance on drugs, biologics, and devices and their application to the development of military-relevant medical solutions.
• Develop and review regulatory strategies, including submission planning, dossier preparation, and communication with regulatory agencies.
• Evaluate and interpret regulatory guidelines, directives, and policies, and assess their impact on developmental programs.
• Prepare and review regulatory submissions, including but not limited to INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting submission packages and minutes, audit and inspection reports.
• Support regulatory agency interactions, including preparation for meetings, communication with Sponsors, responses to queries, and management of commitments.
• Conduct gap analyses of existing processes and documentation against current regulatory requirements.
• Provide training and mentorship to team members on regulatory requirements and best practices.
• Stay current on changes to relevant regulations, guidelines, and industry standards and communicate these changes to the team.
• Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and marketing, to ensure regulatory compliance throughout the product lifecycle.
• Proactively communicate with and advise product managers, IPTs, and leadership on regulatory risks, opportunities, and issues.
• Collaborate as necessary to identify regulatory affairs strategies to optimize product development across the portfolio.
• Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data.
• Facilitate an understanding of requirements for compliance with all applicable FDA regulations.
• Understand and plan for future clinical trials and other pre-clinical trial milestones.
• Coordinate and assist in the review of all pre-clinical trial documents.
• Keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.
• Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.

Degree: Bachelor's degree in a relevant area preferred

Required Certification: Regulatory Affairs Certification (RAC)

Required Experience:

• Minimum eight (8) years of relevant experience required
• Have a strong understanding of the product development lifecycle and regulatory requirements at each stage.
• In depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions.
• Possess strong problem-solving and analytical skills.
• Be able to work independently and as part of a team.

Required Clearance:

• U.S. citizenship required.
• Background investigation.

Job Description

Job Description

Daily Responsibilities:

Help accelerate the development of lifesaving medical products for the Warfighter by serving as a regulatory expert at the forefront of military medical innovation. In this role, you will guide the regulatory strategy for drugs, biologics, medical devices, and other advanced medical solutions, working closely with scientists, clinicians, product managers, and government leaders. Your expertise will directly influence the successful development, approval, and fielding of critical capabilities that support military readiness and improve health outcomes.

• Provide specialized guidance and support and serve as a technical resource, offering in-depth expertise on relevant regulatory requirements, strategies, and processes to ensure successful product development, submission, and lifecycle management.
• Provide expert advice and guidance on drugs, biologics, and devices and their application to the development of military-relevant medical solutions.
• Develop and review regulatory strategies, including submission planning, dossier preparation, and communication with regulatory agencies.
• Evaluate and interpret regulatory guidelines, directives, and policies, and assess their impact on developmental programs.
• Prepare and review regulatory submissions, including but not limited to INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting submission packages and minutes, audit and inspection reports.
• Support regulatory agency interactions, including preparation for meetings, communication with Sponsors, responses to queries, and management of commitments.
• Conduct gap analyses of existing processes and documentation against current regulatory requirements.
• Provide training and mentorship to team members on regulatory requirements and best practices.
• Stay current on changes to relevant regulations, guidelines, and industry standards and communicate these changes to the team.
• Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and marketing, to ensure regulatory compliance throughout the product lifecycle.
• Proactively communicate with and advise product managers, IPTs, and leadership on regulatory risks, opportunities, and issues.
• Collaborate as necessary to identify regulatory affairs strategies to optimize product development across the portfolio.
• Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data.
• Facilitate an understanding of requirements for compliance with all applicable FDA regulations.
• Understand and plan for future clinical trials and other pre-clinical trial milestones.
• Coordinate and assist in the review of all pre-clinical trial documents.
• Keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.
• Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.

Degree: Bachelor's degree in a relevant area preferred

Required Certification: Regulatory Affairs Certification (RAC)

Required Experience:

• Minimum eight (8) years of relevant experience required
• Have a strong understanding of the product development lifecycle and regulatory requirements at each stage.
• In depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions.
• Possess strong problem-solving and analytical skills.
• Be able to work independently and as part of a team.

Required Clearance:

• U.S. citizenship required.
• Background investigation.