FEFA, LLC is seeking a Remote Consulting Regulatory Affairs Program Manager. The position will require ensuring planning, execution, delivery of reports, and accurate and timely communication with clients and other stakeholders. The PM will also organize, and conduct teleconferences as required. Prepare and submit pre- and post-meetings reports while serving as a core member of integrated product teams (IPTs), and a member of the internal regulatory team in support of drug, biologic, and medical device products.

Pay is based on several factors including but not limited to education, work experience, certifications, etc.

POSITION RESPONSIBILITIES:

• Reviewing all regulatory documentation for the product development effort to include reviewing, editing, and coordination of document submissions to the FDA.
• Identifying regulatory issues that need the input of other regulatory Subject Matter Experts (SMEs) and obtaining that input.
• Aiding with clinical and nonclinical protocol development and review.
• Providing guidance on regulatory pathway development and regulatory strategy.
• Providing guidance to IPTs in the conduct of meetings with the FDA.
• Providing guidance to IPTs for the development of contract documents and statements of work (SOWs) for the development of medical devices, drugs, or biologic products.
• Ensure all FDA communications, both formal and informal are documented in the Sponsors Electronic Document Management System (EDMS) for Army Surgeon General-sponsored products.
• Ensuring timely receipt of and providing a regulatory review of all FDA communications for externally sponsored products, serving as a point-of-contact with FDA and regulatory staff of external collaborators.
• Providing regulatory assessment, consult, and regulatory opinion for medical devices, drugs, and biologics.
• Understand and apply Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and/or Quality Systems Regulation (QSR) compliance for medical devices.
• Establishing and complying with standard operating procedures.
• Populating the sponsor’s trial master file for clinical studies and performing audits of trial master files to ensure all documentation is included.

MINIMUM REQUIRED QUALIFICATIONS:

• Experience applying FDA Title 21 CFR for clinical research, regulatory compliance, and quality review of submissions to the FDA relating to product approval.
• Regulatory affairs guidance and policy document development, regulations, and guidelines to meet FDA clinical research compliance, regulations, and guidelines to ensure compliance to design controls for the development of devices.
• Experience in GLP studies and GCP Regulations.
• Experience in coordination of regulatory activities within internal and external teams.
• Solid understanding of the FDA eCTD processes.
• Experience in advising product development teams on regulatory issues.

PREFERRED QUALIFICATION:

• Must be able to work independently following a brief period of specific technical training.

FEFA, LLC, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability