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How much do fda cder jobs pay per year?

As of Jun 6, 2026, the average yearly pay for fda cder in the United States is $78,419.00, according to ZipRecruiter salary data. Most workers in this role earn between $61,000.00 and $90,500.00 per year, depending on experience, location, and employer.

What is an FDA CDER job?

An FDA CDER job refers to a role within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). CDER is responsible for ensuring the safety, effectiveness, and quality of human drugs. Jobs in CDER can include roles in drug review, regulatory science, pharmacology, and policy development. Employees work to evaluate new drug applications, monitor post-market drug safety, and develop guidelines to improve public health. Positions may require expertise in medicine, pharmacy, biology, chemistry, or regulatory affairs.

What are the key skills and qualifications needed to thrive in the Fda Cder position, and why are they important?

To thrive in a role within the FDA's Center for Drug Evaluation and Research (CDER), you typically need a background in pharmaceutical sciences, regulatory affairs, medicine, or related scientific fields, often with an advanced degree such as a PharmD, PhD, or MD. Familiarity with regulatory guidelines (e.g., FDA, ICH), submission management systems, and data analysis tools is commonly required, along with certifications like RAC (Regulatory Affairs Certification) being beneficial. Exceptional analytical thinking, attention to detail, and effective written and verbal communication skills help professionals excel in multidisciplinary team settings. These competencies are essential for ensuring thorough drug evaluation, compliance with regulations, and safeguarding public health.

What are the typical daily responsibilities of someone working at FDA CDER?

At FDA CDER, typical daily responsibilities include reviewing data from drug development and clinical trials, preparing and assessing regulatory submissions, and collaborating closely with colleagues across scientific, legal, and public health disciplines. Professionals may participate in meetings to discuss safety or efficacy issues, draft guidance documents, and respond to inquiries from pharmaceutical companies. Teamwork and cross-disciplinary communication are frequent given the complexity of regulatory decisions. The work is highly detail-oriented and focuses on ensuring that medications are safe and effective for public use.

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Fda Cder jobs near you
Infographic showing various Fda Cder job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $78,419 per year, or $37.7 per hour.

Regulatory Affairs Specialist

LBB SPECIALTIES HOLDINGS LLC

Norwalk, CT • Hybrid

$31.25 - $36.06/hr

Other

Medical, Retirement

Posted 6 days ago

Job description

Regulatory Affairs Specialist

Why Join Us?
At LBB Specialties, we are dedicated to empowering innovation, building meaningful relationships, and fostering an environment where every team member can thrive. As part of our team, you'll work alongside industry experts, contribute to impactful projects, and help drive our company forward in the chemical distribution space. Join us as we bring innovation and growth to the forefront of our industry.

Your Impact
As a Regulatory Affairs Specialist, you will be responsible for assisting the Regulatory Affairs Manager in regulatory submissions and functions. The Regulatory Affairs Specialist will also act as Research Assistant by reviewing and summarizing relevant U.S. state/federal and Canadian regulations.

Key Responsibilities

  • Regulatory/legal research; ability to research, interpret and summarize relevant provisions.
  • Subscribe to all relevant regulatory news portals, read the news, and submit summaries to Director of Regulatory Affairs on a daily basis.
  • Review SDSs and Labels for completeness and accuracy.
  • Research regulatory questions for Principal Managers and Sales Representatives.
  • Perform weekly checks for import alerts and FDA 483 letters to determine if Company suppliers have been listed.
  • Assist in drafting Standard Operating Procedures and Work Instructions for regulatory functions.
  • Act as backup to Regulatory Affairs Manager.
  • Maintain current and orderly files
  • Assist in submitting Regulatory reports to agencies.
  • Assist in identifying and implementing process improvement initiatives.
  • Join relevant regulatory committees such as NACD and RDC, summarize regulatory news/topics and submit to Regulatory Affairs Manager.

What You’ll Bring

  • Bachelor’s degree and 3+ years of regulatory related experience, pharmaceutical/food/chemical industry preferred.
  • Have a thorough understanding of regulations as they apply to writing and reviewing SDSs and labels.
  • Trained in occupational hazard safety and transportation hazard safety regulations (OSHA/DOT/IATA, etc.).
  • Skilled and experienced in regulatory/legal research; ability to research, interpret, and summarize relevant provisions.  This applies to U.S. Federal and State regulations as well as foreign regulations, specifically Canada.
  • Excellent computer skills including (Microsoft Outlook, Excel, Word, PowerPoint).
  • Knowledge of TSCA, OSHA, and FSMA regulations.
  • Familiarity with agency electronic portals FURLS, ODGI, CDER Direct, CDX, etc.
  • Familiarity with monographs; USP, FCC, NF & others.
  • Familiarity with REACH and Canadian regulations.
  • Excellent attention to detail, follow through, organization, time management, and written and verbal communication skills.
  • A proactive, results-driven approach with the ability to work both independently and collaboratively.

Why You’ll Love Working Here

  • Competitive Benefits: Comprehensive healthcare, 401(k) matching, and more.
  • Flexible Work Environment: Hybrid work schedule
  • Professional Development: Access to learning opportunities and resources to grow in your career.
  • Inclusive Culture: Be part of a diverse, collaborative, and supportive team.
  • Industry-Leading Impact: Work with top brands in a dynamic field and contribute to meaningful growth.

Additional Information

  • Location: Norwalk, CT
  • Travel: None
  • Work Authorization: Must be able to show evidence of authorization to work in United States without employer sponsorship.

EEO Statement
LBB Specialties is committed to providing equal employment opportunities for all employees and applicants, celebrating diversity and fostering a supportive, harassment-free work environment.

Disclaimer
This job description is not exhaustive and may be subject to change or additional responsibilities based on business needs.

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