$31.50 - $40.41/hr
... PMDA, HC, TGA, etc). * Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. * Ensure ...
$31.50 - $40.41/hr
... PMDA, HC, TGA, etc). * Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. * Ensure ...
$31.50 - $40.41/hr
... PMDA, HC, TGA, etc). * Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. * Ensure ...
Seattle, WA · On-site
$96K - $120K/yr
Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy ...
Seattle, WA · On-site
$96K - $120K/yr
Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy ...
Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses * Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI ...
Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses * Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI ...
Armonk, NY · On-site
$176K - $287K/yr
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. Ensure compliance ...
Armonk, NY · On-site
$176K - $287K/yr
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. Ensure compliance ...
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. * Ensure compliance ...
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. * Ensure compliance ...
Indianapolis, IN · On-site
Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred. Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we ...
Indianapolis, IN · On-site
Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred. Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we ...
Navigate multiple regulatory requirements including FDA 21 CFR Parts 210/211, 600-680, 820, and 1271, Japan PMDA regulations, and ICH guidelines. * Fully implement an electronic quality management ...
Quick apply
Navigate multiple regulatory requirements including FDA 21 CFR Parts 210/211, 600-680, 820, and 1271, Japan PMDA regulations, and ICH guidelines. * Fully implement an electronic quality management ...
Your proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, EU MDR, and ISO regulations and standards , is essential to our success. Job Responsibilities: Quality ...
Your proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, EU MDR, and ISO regulations and standards , is essential to our success. Job Responsibilities: Quality ...
Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses * Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI ...
Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses * Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI ...
Indianapolis, IN · On-site
Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred. EMBRACING DIVERSITY: Embracing diversity is at the core of our long-held value of respect for people. It is the ...
Indianapolis, IN · On-site
Experience with regulatory interactions (FDA, EMA, PMDA, or other agencies) preferred. EMBRACING DIVERSITY: Embracing diversity is at the core of our long-held value of respect for people. It is the ...
The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and ...
The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and ...
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. * Ensure compliance ...
Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. * Ensure compliance ...
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 ...
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 ...
Seattle, WA · On-site
$95K - $113K/yr
Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy ...
Seattle, WA · On-site
$95K - $113K/yr
Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy ...
Indiana, PA · On-site
$137K - $181K/yr
Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) and lead/facilitate interactions, teleconferences, and meetings. * Provide expert regulatory CMC guidance to ...
Indiana, PA · On-site
$137K - $181K/yr
Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) and lead/facilitate interactions, teleconferences, and meetings. * Provide expert regulatory CMC guidance to ...
Track record overseeing non-US FDA regulatory requirements (EMA, MHRA, Health Canada, PMDA). #J-18808-Ljbffr
New
Track record overseeing non-US FDA regulatory requirements (EMA, MHRA, Health Canada, PMDA). #J-18808-Ljbffr
New
Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada). Preferred: * LIMS experience (stability ...
Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada). Preferred: * LIMS experience (stability ...
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 software ...
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 software ...
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 ...
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 ...
Warren, MI · Remote
$50 - $80/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 ...
Warren, MI · Remote
$50 - $80/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 ...
$17.31 - $19.67
6% of jobs
$21.49 is the 25th percentile. Wages below this are outliers.
$19.67 - $22.03
24% of jobs
$22.03 - $24.39
17% of jobs
The median wage is $24.98 / hr.
$24.39 - $26.75
11% of jobs
$26.75 - $29.11
6% of jobs
$30.62 is the 75th percentile. Wages above this are outliers.
$29.11 - $31.47
17% of jobs
$31.47 - $33.83
7% of jobs
$33.83 - $36.19
4% of jobs
$36.19 - $38.55
6% of jobs
$38.55 - $40.91
1% of jobs
$40.91 - $43.27
0% of jobs
$17
$27
$43
| Aspect | Pmda | Pharmacist |
|---|---|---|
| Required Credentials | Typically requires a specialized certification or training in medical device regulation | Requires a pharmacy degree and licensure |
| Work Environment | Regulatory agencies, medical device companies, healthcare compliance | Community pharmacies, hospitals, healthcare settings |
| Industry Usage | Regulatory and compliance sectors within healthcare | Pharmaceuticals, 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.
Cities with the most Pmda job openings:
States with the most job openings for Pmda jobs include:
The top searched job categories for Pmda jobs are:

Remote
$31.50 - $40.41/hr
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 10 days ago
7.7
Based on 341 frontline employees who took The Breakroom Quiz
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500.
We boast tremendous opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and uplift others, led by leaders with a focus on employee development and well-being, dedicated training programs, and a collaborative atmosphere.
We currently have a career opening for a Scientist I - CMC
What Chemistry, Manufacturing and Controls contributes to Cardinal Health
The Scientist I - CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content.
Location
Remote
Responsibilities
Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities.
Assist as an authoring strategist by organizing and maintaining submission-ready documents in accordance with US FDA and global regulatory requirements (EMA, NMPA, ANVISA, PMDA, HC, TGA, etc).
Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions.
Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations.
Track and manage document timelines and deliverables to support regulatory milestones.
Maintain clear and proactive communication with client stakeholders while operating in a contractor capacity.
Ensures an established level of billable hours per fiscal year
Qualifications:
Bachelor's degree in related field, or equivalent work experience (Pharma QA, QC, Analytical Development), preferred
Familiarity with core CMC concepts (e.g., manufacturing, control strategy, change management) and general awareness of post-approval variation requirements across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred.
Proactive, self-motivated, and able to work independently in a client-facing role.
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Ability to manage multiple tasks and meet deadlines in a dynamic environment.
Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Working knowledge of Adobe Acrobat for document editing, formatting, and publishing.
Team-oriented mindset with the ability to collaborate across functions.
Understanding and application of scientific principles and techniques used in pharmaceutical product development
Knowledge and experience with cGMP regulations and ICH guidance.
Experience with writing global regulatory applications in eCTD format
What is expected of you and others at this level
Applies foundational CMC and regulatory concepts to support project deliverables with attention to quality and detail
Contributes to project activities with increasing autonomy, proactively seeking guidance when needed
Interprets and applies established procedures to address routine technical and regulatory questions
Demonstrates a strong learning mindset, building CMC and global regulatory knowledge (including post-approval lifecycle management) through hands-on project work
Effectively manages assigned tasks and deadlines in a remote setting, showing self-motivation and accountability
Adapts to evolving project priorities and supports multiple client needs as part of a consulting environment
Communicates clearly and collaborates with team members to ensure alignment and progress on deliverables
Supports client projects by delivering high-quality work products and developing regulatory acumen over time
Anticipated hourly range:$31.50 - $40.41 per hour
Bonus eligible:No
Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close: 9/8/26 if interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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Cardinal Health Innovative Delivery Solutions With over 45 years of experience in helping hundreds of hospital and outpatient pharmacies, we provide access to best practice strategies and tactics to control costs, improve workflow and enhance safety. Cardinal Health Innovative Delivery Solutions is one of the largest employers of acute-care pharmacist in the United States. Cardinal Health is the employer of choice for pharmacists because we offer a variety of career opportunities in pharmacy leadership, clinical specialties, remote order entry, business management, medication therapy management and more.
Medical equipment and supplies manufacturing
10,000+ Employees
Dublin, OH, US
1971