Regulatory Affairs Scientist — FDA Strategy & Submissions

CICONIX, LLC; Frederick (MD); On-site; USD 78,000 - 81,000; Full time

Benefits offered by this job

Health benefits

PTO

401k

Job summary

CICONIX LLC is seeking a Regulatory Affairs Scientist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. The role focuses on ensuring FDA sponsor responsibilities compliance, developing regulatory strategies, and supporting submissions to CDER, CBER, and CDRH.

Responsibilities include leading regulatory strategy development, maintaining Target Product Profiles, managing risk registers, and coordinating regulatory documents in EDMS, with a full

Qualifications

• U.S. citizenship and successful background investigation required.
• Ability to obtain and maintain a government security clearance.
• Willingness to comply with government vaccination requirements.

Responsibilities

• Provide regulatory SME support to cross-functional teams on FDA-related activities.
• Lead development of written regulatory strategy and Target Product Profiles; provide to Government.
• Coordinate regulatory submissions and maintain EDMS records.
• Serve as primary FDA contact for assigned products; manage communications and meeting minutes.
• Enter information in ClinicalTrials.gov and ensure regulatory compliance and updates.

Job description

CICONIX LLC is seeking a Regulatory Affairs Scientist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. The role focuses on ensuring FDA sponsor responsibilities compliance, developing regulatory strategies, and supporting submissions to CDER, CBER, and CDRH.

Responsibilities include leading regulatory strategy development, maintaining Target Product Profiles, managing risk registers, and coordinating regulatory documents in EDMS, with a full