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Pmda Jobs in Texas (NOW HIRING)

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Compliance Officers

Austin, 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 ...

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 ...

Compliance Officers

Abilene, 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 ...

Compliance Officers

Garland, 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 ...

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 ...

Compliance Officers

Mckinney, 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 ...

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 ...

Compliance Officers

Tyler, 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 ...

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 ...

Compliance Officers

Mesquite, 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 ...

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 ...

Compliance Officers

El Paso, 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 ...

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 ...

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 1-20

Pmda information

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

To thrive as a PMDA reviewer, you need an advanced degree in pharmaceutical sciences, medicine, or related fields, along with a thorough understanding of drug development and regulatory requirements. Familiarity with regulatory submission systems, guideline databases, and scientific data analysis tools is essential. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for this role. These competencies ensure rigorous evaluation of medical products, safeguard public health, and facilitate clear interactions with stakeholders.

What is a PMDA?

PMDA stands for Pharmaceuticals and Medical Devices Agency, which is a Japanese government agency responsible for reviewing, approving, and monitoring pharmaceuticals, medical devices, and regenerative medicines. They ensure the safety, efficacy, and quality of these products before and after they enter the Japanese market. PMDA also provides consultation services during the development process and post-marketing surveillance to protect public health.

What is the difference between Pmda vs Pharmacist?

AspectPmdaPharmacist
Required CredentialsTypically requires a specialized certification or training in medical device regulationRequires a pharmacy degree and licensure
Work EnvironmentRegulatory agencies, medical device companies, healthcare complianceCommunity pharmacies, hospitals, healthcare settings
Industry UsageRegulatory and compliance sectors within healthcarePharmaceuticals, healthcare, patient care

While Pmda professionals focus on medical device regulation and compliance, pharmacists are licensed healthcare providers specializing in medication dispensing and patient care. Both roles are vital in healthcare but serve different functions and require distinct credentials.

What are some common challenges faced by a PMDA, and how can they be addressed?

One common challenge for a PMDA is balancing the need for timely project updates with ensuring data accuracy and consistency across multiple sources. Since PMDAs often work with cross-functional teams, aligning everyone on standardized data reporting processes can be demanding. Building strong communication channels and implementing robust data validation tools can help overcome these challenges. Additionally, proactively seeking feedback from stakeholders and regularly updating documentation can streamline workflows and support project success.

What cities in Texas are hiring for Pmda jobs?

Cities in Texas with the most Pmda job openings:

Infographic showing various Pmda job openings in Texas as of August 2026, with employment types broken down into 39% Full Time, and 61% Part Time. Highlights an 20% Physical, 3% Hybrid, and 77% Remote job distribution.

Regulatory Affairs Specialist

micro1 AI

Pearland, TX • Remote

$50 - $70/hr

Part-time

This job post has expired 1 day ago. Applications are no longer accepted.


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).