... junior regulatory team members Qualifications Experience * 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products * Proven experience with FDA CDER ...
... junior regulatory team members Qualifications Experience * 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products * Proven experience with FDA CDER ...
Clinical Data Scientist, FDA (Jr.)
Silver Spring, MD · On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Quick apply
Clinical Data Scientist, FDA (Jr.)
Silver Spring, MD · On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Clinical Data Scientist, FDA (Jr.)
Silver Spring, MD · On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Clinical Data Scientist, FDA (Jr.)
Silver Spring, MD · On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Senior Business Analyst / Lead (PMP Certified)
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
Herndon, VA · On-site
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
Herndon, VA · On-site
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
Herndon, VA · On-site
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
Herndon, VA · On-site
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Senior Business Analyst / Lead (PMP Certified)
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Quick apply
Senior Business Analyst / Lead (PMP Certified)
$95K - $122K/yr
... junior analysts. Key Responsibilities Leadership & Stakeholder Management * Lead and mentor a team ... Prior experience with CDER or FDA programs * Knowledge of regulatory submission processes or ...
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)
Redmond, WA · On-site
$150K - $230K/yr
Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level ... junior team members Cross-Functional & External Leadership * Partner with Drug Regulatory (CDER ...
Quick apply
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)
Redmond, WA · On-site
$150K - $230K/yr
Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level ... junior team members Cross-Functional & External Leadership * Partner with Drug Regulatory (CDER ...
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)
Redmond, WA · On-site
$150K - $230K/yr
Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level ... junior team members Cross-Functional & External Leadership * Partner with Drug Regulatory (CDER ...
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)
Redmond, WA · On-site
$150K - $230K/yr
Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level ... junior team members Cross-Functional & External Leadership * Partner with Drug Regulatory (CDER ...
Junior Fda Cder information
See salary details
$22.5K - $31.7K
1% of jobs
$31.7K - $41K
4% of jobs
$41K - $50.2K
11% of jobs
$54.5K is the 25th percentile. Wages below this are outliers.
$50.2K - $59.4K
18% of jobs
The median wage is $66.3K / yr.
$59.4K - $68.6K
21% of jobs
$68.6K - $77.9K
16% of jobs
$81.2K is the 75th percentile. Wages above this are outliers.
$77.9K - $87.1K
11% of jobs
$87.1K - $96.3K
6% of jobs
$96.3K - $105.5K
5% of jobs
$105.5K - $114.8K
3% of jobs
$114.8K - $124K
3% of jobs
$22.5K
$72.5K
$124K
How much do junior fda cder jobs pay per year?
Is FDA on a hiring freeze?
What is the difference between Junior Fda Cder vs Associate Fda Cder?
| Aspect | Junior Fda Cder | Associate Fda Cder |
|---|---|---|
| Required Certifications | Typically entry-level, may include basic FDA or industry certifications | Similar certifications, often with more experience or specialized training |
| Work Environment | Office-based, regulatory compliance, documentation review | Same as Junior, with increased responsibilities |
| Employer & Industry Usage | Pharmaceutical, biotech, and medical device companies regulated by FDA | Same as Junior, often in larger teams or departments |
The main difference between Junior Fda Cder and Associate Fda Cder lies in experience level and responsibility. The Associate role generally requires more experience and involves more complex tasks, but both roles operate within similar environments and industries, focusing on FDA compliance and regulatory documentation.
What are the key skills and qualifications needed to thrive as a Junior FDA CDER, and why are they important?
Is it hard to get hired by the FDA?
What types of projects and responsibilities can a Junior FDA CDER professional expect in their first year on the job?
What is the highest paying job at the FDA?
What are Junior FDA CDER roles?
Is CDER under FDA?
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Regulatory Affairs Principal, Pharmaceutical and Combination Products
Meridian Bioscience, Inc.Remote
Other
Posted 5 days ago
Job description
Meridian Bioscience is a fully integrated life science company developing and delivering innovative diagnostic and life science solutions that improve patient outcomes worldwide. Our work spans discovery to diagnosis, and we are expanding into combination drug-device products that redefine how diseases are detected and managed.
We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform-a unique combination product at the intersection of pharmaceuticals and diagnostics.
Job Summary
The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy.This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products.
Key Duties
- Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages
- Author and review INDs, NDAs, supplements, and other global regulatory submissions
- Serve as a primary interface with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)
- Develop and deliver high-quality briefing documents, responses, and regulatory communications
- Provide regulatory guidance on clinical, nonclinical, and CMC development activities
- Drive combination product regulatory strategy, including coordination with FDA's Office of Combination Products (OCP)
- Advise on labeling strategy, including prescribing information and device components of combination products
- Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways
- Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)
- Stay current on evolving regulatory requirements and translate them into actionable guidance for teams
- Mentor and provide guidance to junior regulatory team members
Qualifications
Experience
- 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products
- Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements
- Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution
- Experience with combination products (drug-device) strongly preferred
- Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance
- Exposure to global regulatory environments (e.g., EMA, ICH) preferred
Education
- Bachelor's degree in a scientific discipline required
- Advanced degree (MS, PhD, PharmD) preferred
Certifications
- RAC (US or Drugs) preferred
Travel
- 0-10%
About Meridian Bioscience
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Cincinnati, OH, US
Year founded
1977