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Pmda Regulatory Jobs (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Tallahassee, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Carrollton, TX · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Jacksonville, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Clearwater, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Gainesville, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Denton, TX · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Round Rock, TX · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Waco, TX · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Richmond, VA · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Ann Arbor, MI · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Birmingham, AL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Allentown, PA · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Spokane Valley, WA · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

South Fulton, GA · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Jackson, MS · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Orlando, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Concord, NC · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Pembroke Pines, FL · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

micro1 AI

Regulatory Affairs Specialist

Buckeye, AZ · Remote

$50 - $70/hr

Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...

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Showing results 41-60

All JobsPmda Regulatory Jobs

Pmda Regulatory information

See salary details

$40.5K

$95.4K

$138.5K

How much do pmda regulatory jobs pay per year?

As of Aug 9, 2026, the average yearly pay for pmda regulatory in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a PMDA regulatory specialist, and why are they important?

To thrive as a PMDA Regulatory Specialist, you need a thorough understanding of Japanese pharmaceutical regulations, regulatory submission processes, and a relevant degree in life sciences or pharmacy. Familiarity with regulatory information management systems, eCTD submissions, and knowledge of PMDA guidelines are typically required, along with certifications such as RAC (Regulatory Affairs Certification) being advantageous. Strong attention to detail, cross-cultural communication, and organizational skills help you effectively navigate complex regulatory requirements and collaborate with stakeholders. These skills ensure the successful approval and compliance of products in the Japanese market, minimizing delays and regulatory risks.

What are some common challenges faced by professionals working in PMDA regulatory roles, and how can they be managed?

Professionals in PMDA regulatory roles often encounter challenges such as navigating evolving Japanese regulations, meeting tight submission timelines, and ensuring precise communication with both internal teams and the PMDA. Staying updated on PMDA guidance and regulatory changes is essential, as is collaborating cross-functionally with clinical, quality, and regulatory affairs teams to prepare comprehensive documentation. Building strong relationships with local stakeholders and utilizing project management tools can help mitigate these challenges and streamline the submission process.

What is a PMDA regulatory professional?

PMDA regulatory professionals are experts who navigate the regulatory requirements set by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). They ensure that pharmaceuticals, medical devices, and other health-related products comply with Japanese laws and guidelines for safety, efficacy, and quality. These professionals prepare and submit applications, communicate with the PMDA, and support companies through the product approval process in Japan. Their role is crucial for bringing new therapies and technologies to the Japanese market.

What is the difference between Pmda Regulatory vs Pmda Compliance Officer?

AspectPmda RegulatoryPmda Compliance Officer
CredentialsRegulatory affairs certifications, knowledge of PMDA regulationsCompliance certifications, understanding of PMDA standards
Work EnvironmentRegulatory agencies, pharmaceutical companies, biotech firmsCorporate compliance departments, pharmaceutical companies
Employer & IndustryPharmaceutical and biotech industries regulated by PMDACompanies adhering to PMDA standards and regulations

Both roles involve working with PMDA regulations, but Pmda Regulatory focuses on navigating regulatory submissions and approvals, while Pmda Compliance Officer emphasizes ensuring ongoing compliance with PMDA standards within organizations.

More about Pmda Regulatory jobs
What cities are hiring for Pmda Regulatory jobs? Cities with the most Pmda Regulatory job openings:
What states have the most Pmda Regulatory jobs? States with the most job openings for Pmda Regulatory jobs include:
What job categories do people searching Pmda Regulatory jobs look for? The top searched job categories for Pmda Regulatory jobs are:
Pmda Regulatory jobs near you
Infographic showing various Pmda Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Regulatory Affairs Specialist

micro1 AI

Tallahassee, FL • Remote

$50 - $70/hr

Part-time

Posted 5 days ago

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

Apply