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FDA REGULATORY ATTORNEY Firm X is seeking an experienced FDA Regulatory Attorney to join its growing FDA and Life Sciences practice. Due to significant client demand and a steady influx of new FDA ...

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Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes. * Own strategy, drafting, and management of ...

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How much do fda regulatory jobs pay per hour?

As of Aug 11, 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:
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 FDA Regulatory Attorney

The Rockridge Group

New York, NY • Remote

$250K - $350K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Job description

TITLE: FDA REGULATORY ATTORNEY

Firm X is seeking an experienced FDA Regulatory Attorney to join its growing FDA and Life Sciences practice. Due to significant client demand and a steady influx of new FDA-related matters, we are looking for an attorney with deep regulatory experience advising pharmaceutical, compounding, medical device, biotechnology, healthcare, and related life sciences clients.

Key Responsibilities:

  • Advise clients on FDA regulatory compliance matters involving drugs, biologics, medical devices, dietary supplements, and compounding pharmacies.
  • Counsel clients regarding FDA regulations, guidance, inspections, investigations, warning letters, and enforcement actions.
  • Provide guidance on:
    • Compounding (503A and 503B)
    • Drug Supply Chain Security Act (DSCSA)
    • cGMP compliance
    • Drug and device manufacturing requirements
    • FDA registrations and annual filings
    • Labeling, marketing, and advertising reviews
    • Product recalls and withdrawals
    • Import/export compliance
    • Veterinary medicine and veterinary compounding
  • Assist with NDA, ANDA, 510(k), PMA, OTC, and other FDA submissions.
  • Advise clients regarding clinical trial compliance, research agreements, informed consent forms, IRB requirements, and related regulatory matters.
  • Review scientific and clinical literature to support regulatory strategies and client guidance.

Qualifications:

  • J.D. from an accredited law school.
  • Licensed and in good standing in at least one U.S. jurisdiction.
  • 10+ years of FDA regulatory experience.
  • Prior law firm experience strongly preferred; exceptional in-house FDA counsel will also be considered.
  • Strong working knowledge of pharmaceutical, medical device, compounding, and healthcare regulatory frameworks.
  • Experience with FDA inspections, 483 responses, warning letters, and compliance programs preferred.
  • Clinical trial experience is a plus.
  • Patent and/or copyright filing experience is a plus.
  • Excellent drafting, analytical, and client counseling skills.

Company Description

About The Rockridge Group:

TRG is a privately held Limited Liability Company committed to connecting businesses with job seekers. We deliver high quality contingent personnel to our clients using our 3-step collaborative engagement model:
Collaborate. We partner with you to understand the unique needs of your business before we propose a solution.
Strategize. Based on your goals and staffing challenges, we develop high impact solutions designed for your industry.
Engage. We work with your team before, during, and after every engagement to deliver 100% satisfaction.
With over ten (10) years experience in the resource solutions sector, principals Greg Donner [link to bio] and Ronald Lom [link to bio] leverage the power of strategic partnership to create a powerful staffing model that improves your quality of hire.