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Pmda Jobs in California (NOW HIRING)

Gateway Recruiting

VP of Trade Compliance

Sunnyvale, CA · On-site

$147K - $197K/yr

Understanding FDA-regulated products and global equivalents (EU MDR, UKCA, PMDA, NMPA, ANVISA, etc.). Governance, Policy, and Risk Management: * Establish and maintain global policies covering: HS ...

Kaygen

Spec 3, Clinical Research

Irvine, CA · On-site

Perform quality checks on clinical documentation to ensure inspection readiness for regulatory and quality audits, including FDA, PMDA, TUV, and other regulatory agencies. * Identify documentation ...

Socket.dev

Director, Solid Oral Formulations

San Diego, CA · On-site

$210 - $220/hr

Lead technical preparation for FDA, EMA, MHRA, PMDA, and other regulatory agency inspections. * Serve as the manufacturing and formulation SME during Pre-Approval Inspections (PAI), regulatory audits ...

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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 are popular job titles related to Pmda jobs in California?

For Pmda jobs in California, the most frequently searched job titles are:

What job categories do people searching Pmda jobs in California look for?

The top searched job categories for Pmda jobs in California are:

What cities in California are hiring for Pmda jobs?

Cities in California with the most Pmda job openings:

Pmda jobs near you
Infographic showing various Pmda job openings in California as of August 2026, with employment types broken down into 36% Full Time, and 64% Part Time. Highlights an 20% Physical, 3% Hybrid, and 77% Remote job distribution.

Scientist II, Drug Product

Revolution Medicines

Redwood City, CA • Hybrid

Full-time

Re-posted 21 days ago

Job description

The Opportunity:

Revolution Medicines is seeking Scientist II to join the Drug Product team within Pharmaceutical Development & Manufacturing (PDM). This role will support the development of solid oral dosage forms for small molecule programs across the RVMD pipeline.

The successful candidate will contribute to formulation and process development activities from early-stage through late-stage clinical/commercial development, working closely with cross-functional partners and CDMOs to ensure robust, scalable, and compliant drug product manufacturing processes.

Key Responsibilities:

  • Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.

  • Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:

    • Preformulation and formulation development.

    • Manufacturing process development.

    • Process scale-up, technology transfer, and process optimization.

    • Process validation and commercial manufacturing support.

  • Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.

  • Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.

  • Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.

  • Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.

  • Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.

  • Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education:

  • A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

  • Ph.D. with minimum of 3+ years of experience or a bachelor's/master's degree with appropriate experience in the pharmaceutical/biotech industry settings.

  • Experience supporting drug product development and manufacturing for small molecules.

  • Demonstrated experience in solid oral dosage formulation and process development for small molecules.

  • Experience working with external partners (CDMOs/CROs) and overseeing outsourced development and manufacturing activities.

  • Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements.

  • Experience contributing to CMC regulatory filings is desirable.

  • Strong technical writing, communication, and problem-solving skills.

  • Ability to manage multiple priorities and thrive in a fast-paced, innovation-driven collaborative environment.

Preferred Skills:

  • Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable. 

    #LI-Hybrid #LI-CT1

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