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Pmda Regulatory Jobs (NOW HIRING)

CEDENT

Regulatory Affairs Specialist

Bedford, MA · On-site

Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA. * Experience with ...

Telix Pharmaceuticals (AMER)

OR · On-site

Maintain awareness of global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and apply them to program-level strategy and execution. Identify regulatory risks and support development of ...

Actithera

Global Regulatory Head

Cambridge, MA · Remote

Represent the company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses ... Monitor regulatory landscapes for RLT advancements and update strategies accordingly. Team ...

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Pmda Regulatory information

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How much do pmda regulatory jobs pay per year?

As of Jul 7, 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 are PMDA regulatory professionals?

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
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Pmda Regulatory jobs near you
Vice President, Global CMC Regulatory

Vice President, Global CMC Regulatory

Revolution Medicines

Redwood City, CA • On-site

$183K - $242K/yr

Full-time

Posted 2 days ago

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM) Regulatory, to lead our global chemistry, manufacturing, and controls (CMC) regulatory strategy and execution across all development programs and commercial assets. This leader will drive regulatory strategy development, lead regulatory interactions, and provide expertise throughout the product lifecycle, from early development to post-approval variations ensuring the timely submission and approval of high-quality CMC regulatory filings to support our company's pipeline and global growth.
The successful candidate will serve as a senior leadership role within Pharmaceutical Development and Manufacturing (PDM) organization, overseeing CMC regulatory activities and ensuring alignment with health authority expectations globally (FDA, EMA, PMDA, NMPA, etc.). The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.
Responsibilities:
Global CMC Regulatory Strategy
  • Develop and execute global CMC regulatory strategies in alignment with product development plans for clinical and commercial programs / marketed products.
  • Provide strategic CMC regulatory leadership to support global filings, approvals, and post-approval lifecycle management.
  • Proactively identify and manage CMC regulatory risks, anticipate challenges and develop mitigation strategies to support business objectives and ensure global alignment and compliance.

Health Authority Engagement
  • Serve as the primary CMC regulatory interface with global health authorities, including FDA, EMA, EU National Competent Authorities, and PMDA.
  • Lead and support CMC-related regulatory meetings, scientific advice, and responses to health authority questions.

Regulatory Submissions & Lifecycle Management
  • Oversee the preparation, review, and submission of high-quality CMC sections for NDAs, MAAs, J-NDAs, and global post-approval variations.
  • Ensure consistency, compliance, and scientific rigor across global CMC regulatory filings.
  • Provide strategic oversight for post-approval changes, including site changes, process improvements, and supply chain optimization.
  • Interpret and apply evolving CMC regulatory requirements and guidance globally.

Cross-Functional Collaboration
  • Partner closely with Drug Substance, Drug Product, Analytical Development and QC, Manufacturing, Supply Chain, Quality, and Program Management to align regulatory strategy with technical and operational plans.
  • Act as a regulatory subject matter expert for tech transfer, global site registration, comparability protocols and control strategy development.

Team Development & Leadership
  • Build, mentor, and lead a high-performing global CMC regulatory team, fostering accountability, development, and innovation.
  • Manage external regulatory consultants and regional partners to ensure consistent global execution and local expertise.

Required Skills, Experience and Education:
  • Advanced degree (PhD, PharmD, or MS) in Chemistry, Pharmaceutical Sciences or related scientific discipline.
  • Minimum of 18 years of experience in the biotech/pharmaceutical industry, with at least 10 years in CMC regulatory affairs and global submission experience.
  • Demonstrated success leading global CMC regulatory strategies for small-molecule products.
  • Proven success scaling CMC regulatory function in a public, late-stage biotech/pharma company.
  • Deep understanding of global regulatory frameworks and guidelines (FDA, ICH, EMA, PMDA, NMPA, etc.).
  • Strong leadership and collaboration skills with a demonstrated ability to work cross-functionally and influence stakeholders at all levels.
  • Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and risk.
  • Ability to thrive in a fast-paced, matrixed, and science-driven environment.

Preferred Skills:
  • Experience with oncology development programs and familiarity with accelerated or expedited pathways.
  • Experience with Japan-specific CMC regulatory requirements (e.g., consultations, GQP/GMP compliance, J-NDA format).
  • Exposure to lifecycle management activities including global variations, site changes, and supply chain adaptations.
    #LI-Hybrid #LI-GL1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
Base Pay Salary Range
$294,000-$367,000 USD
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

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