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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 ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$99K - $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 ...

Join Parachute

Manager, Regulatory Affairs

Austin, TX · On-site

Author, review, and submit regulatory filings to FDA/CBER and other regulatory bodies, including BLA supplements, amendments, annual reports, and state licensing applications. * Partner cross ...

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 ...

Join Parachute

Manager, Regulatory Affairs

Austin, TX · On-site

Author, review, and submit regulatory filings to FDA/CBER and other regulatory bodies, including BLA supplements, amendments, annual reports, and state licensing applications. * Partner cross ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$99K - $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

$99K - $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 ...

5th HQ

Regulatory Support Specialist

Miramar, FL

$17 - $19/hr

This role is responsible for ensuring compliance with FDA regulations and maintaining regulatory documentation related to manufacturing, packaging, labeling, and holding operations for dietary ...

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Fda Regulatory information

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$18

$39

$62

How much do fda regulatory jobs pay per hour?

As of Jun 20, 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 the Fda Regulatory position, and why are they important?

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 job?

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 someone working in an FDA Regulatory position?

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.

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 June 2026, with employment types broken down into 1% As Needed, 98% Full Time, and 1% Part Time. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Technical Writer - FDA

Technical Writer - FDA

DRT Strategies, Inc.

Silver Spring, MD • On-site

$70K - $90K/yr

Full-time

Posted 4 days ago

Job description

Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description:
The Technical Writer will provide comprehensive writing and editing support for the FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Manufacturing Quality (OMQ).
Job Summary:
The Technical Writer will support OMQ's regulatory compliance and enforcement activities by drafting, reviewing, and editing a wide range of FDA compliance-related documentation. The Technical Writer will work collaboratively with FDA program offices, legal counsel, and subject matter experts to produce clear, accurate, and consistent communications that meet federal requirements and FDA style guidelines. This position requires strict adherence to confidentiality standards, as the role involves handling sensitive pre-decisional government information.
Responsibilities:
  • Warning Letters: Draft, review, and edit warning letters issued to regulated entities for violations of FDA regulations, ensuring technical accuracy, regulatory citation precision, and adherence to FDA's warning letter format, tone, and enforcement policies.
  • Import Alerts: Develop and edit import alert documentation for products subject to detention without physical examination, ensuring clarity in describing violations, affected products, and guidance for industry compliance, while maintaining consistency with Customs and Border Protection coordination requirements.
  • Regulatory Discretion Documents: Draft policy statements and guidance documents outlining FDA's enforcement discretion positions, ensuring clear articulation of scope, conditions, and limitations, and verifying alignment with applicable statutory and regulatory frameworks.
  • Regulatory Meeting Materials: Prepare briefing documents, meeting agendas, summary reports, and presentation materials for regulatory meetings with industry, advisory committees, and other stakeholders; edit meeting minutes and follow-up correspondence for accuracy and completeness.
  • Performance Goal Analysis: Analyze and synthesize performance data related to FDA's annual reporting requirements and draft narrative sections explaining performance outcomes, trends, and contextual factors.
  • External Stakeholder Talking Points: Develop concise, accurate talking points for FDA leadership and staff communications with external stakeholders, adapting technical content for diverse audiences including industry, consumer advocates, Congress, and media.
Required Experience:
  • A minimum of 5-8 years of professional experience in technical writing, preferably within federal contracts or the Department of Defense (DoD) environment.
  • Demonstrated expertise in federal regulatory writing and FDA-specific documentation standards is strongly preferred.
  • Proven ability to incorporate feedback from subject matter experts and legal reviewers efficiently and meet established deadlines while maintaining high quality standards.
  • Experience handling sensitive or pre-decisional government information with strict confidentiality.
  • Familiarity with a style guide (e.g., AP, AMA).
Preferred Experience:
  • Experience with the FDA, regulatory, healthcare, laboratory, pharmaceutical industry.
  • Advanced proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.) and tools such as SharePoint and Adobe Acrobat.
  • Experience with Visual Basic, EndNote, Adobe Acrobat.
  • Familiarity with Section 508 compliance.
Education & Training:
  • A Bachelor's degree in one of the following fields: English, Journalism, Communications, Engineering, or a technical discipline (Engineering, Computer Science, Biological sciences).
Work Authorization, Clearance Requirement, & Additional Information:
  • This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
  • No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:
  • $70,000 - $90,000
  • Salary commensurate with experience.

DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email.

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