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Fda Cder Jobs in California (NOW HIRING)

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

All JobsFda Cder JobsFda Cder Jobs in California

Fda Cder information

See California salary details

$34K

$77.4K

$125.3K

How much do fda cder jobs pay per year?

As of Aug 23, 2026, the average yearly pay for fda cder in California is $77,392.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,200.00 and $89,300.00 per year, depending on experience, location, and employer.

What is an FDA CDER?

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 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.

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 popular job titles related to Fda Cder jobs in California?

For Fda Cder jobs in California, the most frequently searched job titles are:

What job categories do people searching Fda Cder jobs in California look for?

The top searched job categories for Fda Cder jobs in California are:

Fda Cder jobs near you
Infographic showing various Fda Cder job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $77,392 per year, or $37.2 per hour.

Senior Director, Regulatory Affairs

Ardelyx

Newark, CA

$259K - $317K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 13 days ago

Job description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact - both within our company and in the lives of patients we serve.

Position Summary:

The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio. This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring full compliance with applicable regulations and guidance.

Responsibilities:

  • Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
  • Serve as the primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial objectives
  • Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriate
  • Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements
  • Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications
  • Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategy
  • Lead preparation and execution of IND/CTA submissions and amendments; oversee clinical hold response strategy
  • Drive BLA/NDA/MAA submission planning and execution, including authoring and reviewing Module 2 summaries and managing cross-functional submission teams
  • Oversee preparation, review, and submission of major regulatory filings (IND, BLA/NDA, MAA) and post-approval submissions (CBEs, PASs, supplements, annual reports)
  • Establish and maintain submission timelines, resource plans, and submission-readiness frameworks
  • Ensure eCTD compliance and maintain submission infrastructure in partnership with Regulatory Operations
  • Build, mentor, and retain a high-performing regulatory affairs team
  • Monitor and interpret new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess impact on programs and communicate to leadership

Qualifications:

  • Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience
  • Demonstrated success leading BLA, NDA, or MAA submissions from initiation through approval
  • Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working knowledge of EMA and other major regulatory frameworks
  • Proven track record of leading Health Authority meetings and managing complex, high-stakes regulatory interactions
  • Experience in clinical regulatory strategy, including protocol design input, trial design, and endpoint negotiation with agencies
  • Strong leadership skills with experience managing and developing teams of regulatory professionals
  • RAC certification (RAPS) is a plus
  • Experience across multiple therapeutic areas or modalities (small molecule, biologics, gene therapy, combination products) desirable
  • Global regulatory experience including ex-US submissions and agency interactions desirable
  • Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs preferred
The anticipated annualized base pay range for this full-time position is $259,000 - $317,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.
Employment Type: Full-Time

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