ZipRecruiter

Log In

1

Fda Regulatory Jobs (NOW HIRING)

CICONIX, LLC

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 ...

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$101K - $125K/yr

S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets). * Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$101K - $125K/yr

S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets). * Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$101K - $125K/yr

S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets). * Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 ...

previous pagenext page

Showing results 21-40

All JobsFda Regulatory Jobs

Fda Regulatory information

See salary details

$18

$39

$62

How much do fda regulatory jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for fda regulatory in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in an FDA Regulatory position?

To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.

What is an FDA Regulatory?

An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.

What are the main responsibilities of an FDA Regulatory?

Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

How can I get into FDA regulatory?

To pursue a career in FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or regulatory affairs, along with knowledge of FDA regulations and compliance processes. Gaining relevant experience through internships, certifications such as RAC (Regulatory Affairs Certification), and understanding of medical device or pharmaceutical development can improve job prospects. Strong communication skills and familiarity with regulatory submission tools are also beneficial.
More about Fda Regulatory jobs
What cities are hiring for Fda Regulatory jobs? Cities with the most Fda Regulatory job openings:
What are the most commonly searched types of Fda Regulatory jobs? The most popular types of Fda Regulatory jobs are:
What states have the most Fda Regulatory jobs? States with the most job openings for Fda Regulatory jobs include:
What job categories do people searching Fda Regulatory jobs look for? The top searched job categories for Fda Regulatory jobs are:
Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Senior Regulatory Affairs Scientist

CICONIX, LLC

Fort Detrick, MD

Full-time

Medical, Retirement, PTO

Re-posted 22 days ago

Job description

Senior 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:
  • Possess a Regulatory Affairs Certification (RAC).
Summary:
CICONIX is seeking a Senior Regulatory Affairs Scientistto 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.
.
About the Role:
  • 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. Regulatory Affairs support includes but is not limited to the following:
    • 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 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.
    • Provide regulatory assistance for Quality Management System assessments done at the manufacturing 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.
    • Train, and develop regulatory staff, managing workloads and ensuring alignment with project and program objectives.
    • Lead and/or actively participate in working groups for ORA process improvement, continued learning, regulatory intelligence, and quality review.
    • Write, review, and/or revise SOPs.
    • Provide subject matter expertise on all FDA regulatory matters related to assigned regulatory projects; monitor emerging regulations (United States and global), trends, and agency expectations to assess impact and advise ORA leadership and the sponsor's representative.
.
Qualifications:
  • Education:
    • TBD
  • Licensure & Certifications (Current & Unrestricted):
    • Possess a Regulatory Affairs Certification (RAC).
  • 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: TBD
.
*This position is contingent and will begin upon contract award.
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
#LI-AD1
Employment Type: Full-Time

Apply