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Fda Officer Jobs in Alabama (NOW HIRING)

Madrigal Pharmaceuticals

Rezdiffra is the first and only medication approved by both the FDA and European Commission for the ... The Senior Director partners closely with the Global Compliance Officer, Chief Legal Officer, and ...

Evonik

Manufacturing Specialist

Birmingham, AL · On-site

Ensure regulatory compliance (FDA, EMA, IPEC, ISO) within manufacturing operations. * Train ... Support CMO readiness and participate in client interactions, including site tours and meetings.

DCH Health System

Laboratory Manager

Tuscaloosa, AL · On-site

Works with the System Compliance Officer to ensure laboratory billing is accurate. Assists the ... Comply with accreditation agency standards, FDA, CLIA and other regulatory entities as required.

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Fda Officer information

What is an FDA officer?

FDA Officers are professionals who work for the U.S. Food and Drug Administration (FDA), a federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and other products. Their duties typically include inspecting facilities, evaluating products for compliance with regulations, investigating violations, and ensuring that manufacturers follow safety standards. FDA Officers play a key role in safeguarding the nation’s health by enforcing laws and overseeing the approval process for new products before they reach the market.

What are the key skills and qualifications needed to thrive as an FDA officer?

To thrive as an FDA Officer, you typically need a background in life sciences, pharmacy, or public health, with relevant degrees and/or regulatory certifications. Familiarity with regulatory submission systems, compliance databases, and quality management tools is crucial. Strong analytical thinking, attention to detail, and effective communication skills help you interpret regulations and collaborate with stakeholders. These abilities are vital to ensure public safety, regulatory compliance, and the integrity of food and drug oversight.

What are some common challenges faced by FDA officers in ensuring regulatory compliance within organizations?

FDA Officers often navigate complex and evolving regulations while ensuring that their organization remains fully compliant with federal standards. A common challenge is staying updated on frequent regulatory changes and accurately interpreting how these changes impact internal processes. Additionally, FDA Officers must effectively communicate compliance requirements across different departments and foster collaboration to implement necessary changes. Balancing strict regulatory demands with business objectives and timelines can also require strong problem-solving and negotiation skills.

What is the difference between Fda Officer vs Fda Investigator?

AspectFda OfficerFda Investigator
Required CredentialsBachelor's degree, often in life sciences or related fields; sometimes advanced degreesBachelor's or higher in sciences; specialized training in investigations
Work EnvironmentOffice-based, regulatory compliance, policy enforcementFieldwork, inspections, investigations at facilities or sites
Employer & Industry UsageU.S. Food and Drug Administration, regulatory agenciesU.S. Food and Drug Administration, enforcement division
Common Search & ComparisonRegulatory roles, compliance, policyInspections, enforcement, compliance investigations

Fda Officers primarily focus on regulatory compliance, policy enforcement, and overseeing food and drug safety from an office setting. In contrast, Fda Investigators conduct field inspections and investigations at facilities to ensure compliance. Both roles require similar educational backgrounds but differ in work environment and daily responsibilities.

How to become an FDA officer?

To become an FDA officer, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences, along with experience in regulatory or scientific roles. Many positions require passing the U.S. Office of Personnel Management's civil service exam and obtaining specialized training or certifications related to food and drug regulation. Strong analytical skills, attention to detail, and knowledge of FDA regulations are essential for success in this role.

What are popular job titles related to Fda Officer jobs in Alabama?

For Fda Officer jobs in Alabama, the most frequently searched job titles are:

What job categories do people searching Fda Officer jobs in Alabama look for?

The top searched job categories for Fda Officer jobs in Alabama are:

What cities in Alabama are hiring for Fda Officer jobs?

Cities in Alabama with the most Fda Officer job openings:

Fda Officer jobs near you
Infographic showing various Fda Officer job openings in Alabama as of June 2026, with employment types broken down into 85% Full Time, 13% Part Time, 1% Temporary, and 1% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

CLINICAL RESEARCH REGULATORY COORDINATOR III

Birmingham, AL • On-site

UAB NOVA RENT
See more jobs at UAB NOVA RENTexternal

$55K - $71K/yr

Full-time

Re-posted 25 days ago

Job description

The University of Alabama at Birmingham (UAB), Department of Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Regulatory Coordinator III.
This job position functions as a senior-level regulatory specialist with UAB regulatory expertise. This is considered a lead position, and the candidate must understand he/she is also responsible for reporting metrics (timelines, trends, compliance-related issues), timeliness (meeting deadlines), and providing leadership and/or training to junior staff. Core responsibilities include project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events). Responsibilities also include documentation oversight (regulatory binders, eISFs, logs, etc.), ensuring all documents meet ICH-GCP, FDA, OHRP, and UAB policies, and compliance monitoring (must be knowledgeable of federal regulations, human subjects protections, HIPAA, and informed consent processes).
General Responsibilities
  • To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
  • To prepares and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
  • To lead the implementation of study specific regulatory processes of a moderate to complex nature.
  • To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.
  • To design and implement quality initiatives ensuring effective and efficient clinical processes.

Key Duties & Responsibilities
  1. Subject matter expert for complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation.
  2. Prepares for and helps lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits. Identifying compliance gaps and implementing processes for corrective action planning is required.
  3. Maintains standardized regulatory practices across multiple studies with multiple PIs is required. Must be competent in using a variety of electronic platforms as well as competent in the knowledge of FDA regulations, HSP, UAB research processes, and IRB submission processes.
  4. Performs other duties as assigned.

Annual Salary Range : $55,180 - $71,735
Qualifications
Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
Preferences
  • Have strong project management and risk assessment skills.
  • Be able to communicate effectively with staff, investigators, sponsor representatives, legal officers, and other clinical trials administrative staff.
  • Possess great computer skills, have experience with Microsoft Office, be able to engage in group meetings and discussions, must be able to actively work closely with others and under the leadership of Investigators and senior research coordinators in a variety of settings, and have a strong work ethic.
  • Must also be knowledgeable of UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.

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