ZipRecruiter

Log In

1

Pmda Regulatory Jobs (NOW HIRING)

Contraline, Inc.

Vice President, Regulatory Affairs

$200K - $275K/yr

Global regulatory affairs experience supporting EMA, MHRA, PMDA, Health Canada, TGA, and other international regulatory authorities. * Experience with medical device strategies and submissions (i.e ...

Gilead

Exec Director, Regulatory Affairs

Foster City, CA · On-site

$174K - $230K/yr

Maintain deep expertise in global diagnostic regulations (FDA, EU IVDR, PMDA, NMPA, etc.) and assess impact on development and registration activities. * Monitor evolving regulatory landscape and ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways. * Anticipate regulatory risks and proactively develop ...

Gilead

Exec Director, Regulatory Affairs

Parsippany, NJ · On-site

$150K - $199K/yr

Maintain deep expertise in global diagnostic regulations (FDA, EU IVDR, PMDA, NMPA, etc.) and assess impact on development and registration activities. * Monitor evolving regulatory landscape and ...

next page

Showing results 1-20

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 Jul 14, 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
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

Sr. Manager Global Regulatory Strategy

Alcon Laboratories Holding Corporation

Fort Worth, TX • On-site

Full-time

Medical, Life, Retirement

Re-posted yesterday

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?
Alcon is looking to hire a Sr. Manager Global Regulatory Strategythat will lead regulatory strategy development for emerging and next generation contact lens technologies spanning new product development (NPD), lifecycle management, and business development & licensing (BD&L) activities.

This role is on-site in our Fort Worth, Texas or Johns Creek, GA location and a typical day would include:

Portfolio Scope:

  • Develop global regulatory strategies for novel contact lens platforms, including new optical designs, and innovative material compositions - many of which are early-stage with wearing modality, indication, material, and branding still to be determined.
  • Lead regulatory strategy for new therapeutic and specialty indications, with particular attention to pediatric populations and evolving global regulatory frameworks
  • Drive cross-brand lifecycle initiatives, including multi-product labeling changes (e.g., harmonized Instructions for Use), and cross-portfolio regulatory impact assessments
  • Provide regulatory due diligence and strategic guidance for BD&L opportunities, evaluating regulatory pathway complexity, risk, and timeline implications for potential partnerships, acquisitions, or in-licensing agreements

What Makes This Role Unique:

  • You will serve as the GRA lead on cross-functional teams for foundational platform technologies intended to enable future product families - requiring comfort with ambiguity and the ability to provide strategic regulatory direction when the product profile is not yet fully defined
  • You will define market-specific classification and registration strategies across priority jurisdictions (US FDA, EU MDR, China NMPA, Health Canada, China NMPA, Japan PMDA and others), including assessment of higher-risk classification pathways for novel indications.
  • You will engage with health authorities proactively through pre-submission interactions and advisory meetings to establish regulatory precedent for first-in-class technologies
  • You will partner closely with R&D, Clinical, and Commercial teams from ideation through launch, translating early technical and clinical data into actionable regulatory strategies
  • You will contribute to regulatory digital transformation, including utilization of Veeva RIM and emerging AI-enabled tools for submission planning.

What You'll Bring to Alcon:

  • Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
  • The ability to fluently read, write, understand and communicate in English
  • 7 Years of Relevant Experience
  • 5 Years of Demonstrated Leadership

Preferred Qualifications

  • Extensive experience in regulatory affairs for contact lens and vision care medical device products
  • Demonstrated experience with global regulatory strategies for novel or first-in-class medical devices, including early-stage health authority engagement
  • Familiarity with pediatric device regulatory requirements and clinical study design considerations
  • Experience with Veeva RIM or equivalent regulatory information management systems
  • Experience supporting BD&L regulatory due diligence is a strong plus

How You Can Thrive at Alcon:

  • See your career like never before with focused growth and development opportunities
  • Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
  • Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.
  • Travel up to 10%

Alcon Careers

See your impact at alcon.com/careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.comand let us know the nature of your request and your contact information.

Apply