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Fda Regulatory Jobs (NOW HIRING)

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 ...

Noblis

Principal Regulatory Scientist

Reston, VA · On-site

Demonstrated experience applying FDA regulatory requirements, guidance, and development pathways to assess evidence gaps, regulatory risks, and recommended next steps for medical countermeasure ...

Lexitas

Director, Regulatory Affairs (Fractional)

$153K - $202K/yr

Proven FDA submission and agency interaction expertise * Ability to develop regulatory strategy while driving tactical execution * Experience supporting product development from early-stage through ...

Fujifilm

FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Company Overview At FUJIFILM Healthcare Americas ...

CorDx

Regulatory Affairs Specialist

Alpharetta, GA · On-site

Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards * Working on analytical performance test with product development teams to draft documentation.

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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.
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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 Director / Executive Director, US Regulatory Strategy

VCLS

San Francisco, CA • On-site

Full-time

Re-posted 13 days ago

Job description

We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies. 
The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. 
In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement. 

Key Responsibilities 

Regulatory Strategy Leadership 
Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management. 
Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics. 
Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy. 
Lead all aspects of health authority interactions
Support regulatory due diligence activities. 
Experience with EMA and other international health authorities is highly valued. 
Client Leadership and Consulting 
Serve as a senior strategic advisor and primary client contact. 
Build long-term biotech and pharmaceutical client relationships. 
Lead multidisciplinary consulting teams and mentor junior staff. 
Deliver high-quality regulatory recommendations, reports, and presentations. 
Business Development and Growth 
Support business development, proposals, and client pitches. 
Represent the organization at conferences and industry events. 
Develop thought leadership materials and support company growth. 

Requirements

Required Qualifications 

Degree in a life sciences discipline 

Significant industry experience 

Deep expertise in US FDA regulatory strategy for biologics. 

Multiple successful BLA experiences with direct FDA interactions. 

 Significant experience with complex modalities, such as combination products and cell and gene therapies 

Strong consulting, leadership, communication, and presentation skills. 

Apply