ZipRecruiter

Log In

1

Fda Jobs in Bothell, WA (NOW HIRING)

Jobtailor

Director, Pharmacovigilance

Seattle, WA · On-site

$110 - $180/hr

Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines) * Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity * Support ...

Immunome, Inc.

Director, Toxicology

Bothell, WA · On-site

FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early ...

previous pagenext page

Showing results 21-40

All JobsFda JobsFda Jobs in Bothell, WA

Fda information

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or healthcare. Many positions require specialized knowledge, experience, or advanced degrees, and some roles may require professional certifications or licenses. Strong analytical skills, attention to detail, and familiarity with regulatory guidelines are also important.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What are popular job titles related to Fda jobs in Bothell, WA?

For Fda jobs in Bothell, WA, the most frequently searched job titles are:

What job categories do people searching Fda jobs in Bothell, WA look for?

The top searched job categories for Fda jobs in Bothell, WA are:

What cities near Bothell, WA are hiring for Fda jobs?

Cities near Bothell, WA with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Bothell, WA as of August 2026, with employment types broken down into 64% Full Time, 13% Part Time, and 23% Contract. Highlights an 93% In-person, and 7% Remote job distribution.

Director, Pharmacovigilance

Jobtailor

Seattle, WA • On-site

$110 - $180/hr

Other

Re-posted 2 days ago

Job description

Responsibilities
  • Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
  • Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
  • Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
  • Support maintenance of safety databases and related systems
  • Lead preparation of DSURs, PSURs/PBRERs, and IND safety reports
  • Support safety sections of regulatory submissions and responses to health authority queries
  • Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)
Requirements
  • Advanced degree (PharmD, PhD, MD, or MS) or health‑related degree/certification (PA, RN, NP)
  • At least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry
  • Experience supporting clinical‑stage programs
  • Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
  • Familiarity with aggregate reporting and signal detection processes
  • Experience in oncology, cell therapy, or gene therapy preferred
#J-18808-Ljbffr

Apply