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Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a Manager in FDA Consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a Manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

How does a Manager in FDA Consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
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Infographic showing various Manager Fda Consulting job openings in the United States as of July 2026, with employment types broken down into 93% Full Time, 4% Part Time, and 3% Contract. Highlights an 84% Physical, 4% Hybrid, and 12% Remote job distribution.
Commissioned Inspector - FDA Tobacco Inspection Program

Commissioned Inspector - FDA Tobacco Inspection Program

Bizzell Group

Charlotte, NC โ€ข On-site, Remote

Part-time

Re-posted 16 days ago


Job description

Location: Statewide, North Carolina
Job Type: Contract, Part-Time
Headquarters: New Carrollton, MD
Overview
Bizzell is a consulting, strategy, investment and technology firm with a mission to improve lives and accelerate positive change. We deliver award-winning services to a diverse portfolio of clients to help build healthy, secure, connected and sustainable communities in our nation and around the world. Bizzell's multi-disciplinary team works in health solutions, workforce innovation, managed services, and global programs. Specifically, they offer expertise in program management, research and evaluation, communication and outreach, training and technical assistance, policy analysis, and development.
Key Responsibilities
Compliance Inspections & Enforcement
  • Conduct Undercover Buy (UB) and Advertising & Labeling (A&L) inspections at licensed tobacco retail outlets.
  • Ensure compliance with FDA and North Carolina guidelines related to tobacco sales and marketing.
  • Properly document findings and maintain compliance with chain of custody protocols for evidence storage.
  • Coordinate with state and federal program officials to support compliance enforcement actions.
  • Provide testimony and declarations for enforcement or judicial actions when required.

Data Collection & Reporting
  • Accurately enter inspection results into the FDA Tobacco Inspection Management System (TIMS).
  • Prepare and submit detailed reports on findings in alignment with FDA program requirements.
  • Participate in routine quality assurance reviews to ensure inspection accuracy and procedural adherence.

Training & Professional Development
  • Complete annual training and certification to maintain FDA Commissioned Inspector status.
  • Attend regular program meetings and refresher training sessions to stay updated on federal and state regulations.

Why Join Us?
  • Make an impact by enforcing tobacco control laws that protect public health.
  • Gain valuable experience in regulatory enforcement and federal compliance programs.
  • Work as part of a highly trained team dedicated to upholding public health and safety standards.

Interested candidates should submit their resume and cover letter, detailing relevant experience and qualifications.
Requirements
Education & Experience
  • Law enforcement or regulatory compliance experience is strongly preferred.
  • Strong attention to detail and the ability to follow strict compliance protocols.

Additional Requirements
  • Ability to work flexible hours and travel statewide as needed.
  • Must be able to pass a FDA clearance.
  • Must have a valid driver's license and reliable transportation.

Technical & Administrative Skills
  • Ability to document findings accurately and submit reports in a timely manner.
  • Strong communication and observational skills
  • Familiarity with federal and state tobacco control laws is a plus.