CICONIX

Integrated consulting and biomedical research support

Regulatory Affairs Scientist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeFrederick, MD, USAIn-person

About the Job

Requirements

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

Responsibilities

Provide subject-matter expertise on regulatory matters for assigned projects and keep ORA leadership and the sponsor’s representative updated through periodic reports.
Provide regulatory support to an integrated product team or working group by advising team members on FDA-related activities and issues, attending meetings, and updating ORA leadership and the sponsor’s representative through routine reports.
Lead development of a written regulatory strategy describing the FDA regulatory pathway for approval, licensure, or clearance; possible post-marketing commitments; and the target product profile or equivalent for use throughout development, and provide it to the Government.
Create or provide input to and maintain Target Product Profiles and provide them to the Government. Include indication and usage; dosage and administration; dosage forms and strengths; contraindications; warnings and precautions; safety, adverse reactions, and drug interactions; use in specific populations; drug abuse, dependence, and overdose; drug description; clinical and pharmaceutical information; pre-clinical toxicology; clinical studies; references; storage and handling; patient counseling; risk evaluation and mitigation strategy; and supporting documentation or templates as appropriate.
Identify and mitigate regulatory risk through a project Risk Register.
Serve as primary FDA contact for assigned products; review, analyze, and respond to FDA communications and meetings by regulatory deadlines; and maintain meeting minutes in the Electronic Document Management System.
Coordinate, prepare, write, review, obtain, maintain, and archive required regulatory submission documents in the Electronic Document Management System.
Participate and represent the regulatory subject-matter expert in on-site visits to industry partner manufacturing facilities as requested by ORA or external consultants.
Assist with writing or reviewing abstracts, papers, and publications in collaboration with study team members and submit them to appropriate approval authorities.
Enter clinical study information in ClinicalTrials.gov before study initiation; provide quality assurance for entered data and information; ensure compliance with current regulatory, DHA, and ORA requirements, including uploading required documents, verifying records at least every six months, and updating changes within 30 days; and enter clinical study results no later than 12 months after the study’s primary completion date.
Review acquisition milestone decision briefings, progress reviews, and other acquisition documents and provide written critical regulatory feedback.

Description

Regulatory Affairs Scientist

About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.

Location(s): Fort Detrick, MD

Position Details:

Full-time position
Regular weekly hours (0900-1600)
No calls, nights, weekends, or holidays!
Full benefit program, including: health, PTO, & 401k + contribution

Requirements:

Summary:

CICONIX is seeking a Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions.

About the Role:

Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports.
Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team on any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor’s representative through routine reports.
Lead the development of a written regulatory strategy and provide to the Government The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
Create or provide input to and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
Identify and mitigate regulatory risk through a project Risk Register.
Serve as the primary contact with the FDA for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in the Electronic Document Management System (EDMS).
Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS.
Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested facility performed by ORA or external consultants.
Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities.
Enter information in ClinicalTrials.gov for clinical studies prior to study initiation. Provide quality assurance for the data and information entered, and ensure compliance with the current regulatory, DHA, and ORA requirements to include upload of required documents, record verification at least once every 6 months, and updates within 30 days for changes to recruitment status, sponsor IRB, approval etc. Enter clinical study results NLT 12 months after the study’s primary completion date.
Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents.

Qualifications:

Education:
- TBD
Licensure & Certifications (Current & Unrestricted):
- TBD
Experience:
- TBD
Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
Additional Requirements:
- Willingness to comply with the government vaccination requirements.

Compensation: $78k - $81k

CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.

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Compensation: 81000.00 to 83000.00

About the Company

CICONIX

Integrated consulting and biomedical research support

CICONIX provides an integrated suite of consulting and diagnostic support services for health and human services challenges, with a particular focus on program development and biomedical research assistance to advance healthcare for America's Warfighter community. Its offerings combine advisory services and diagnostic support to help clients design and implement programs, guide biomedical research efforts, and identify opportunities to improve operations across their business lines. The company differentiates itself through its end-to-end, integrated approach and its specialization in military healthcare needs, along with a commitment to maintaining a strong work-life balance for its employees. CICONIX aims to help clients capitalize on opportunities for enhanced operational success while delivering a supportive workplace for its staff.

Company size: 11-50
Company stage: Not listed
Total funding: Not listed
Headquarters: Annapolis, MD
Founded: 2012

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