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Manager Fda Consulting Jobs (NOW HIRING)

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

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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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Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in the United States as of May 2026, with employment types broken down into 79% Full Time, 14% Part Time, and 7% Contract. Highlights an 93% In-person, and 7% Hybrid job distribution.

Senior Regulatory Affairs Specialist -FDA Medical

Wacker Chemie AG

Ann Arbor, MI • On-site

Full-time

Posted 6 days ago

Job description

Ann Arbor, MI, USA, 48108
Posting Start Date: 6/1/26
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
To strengthen our team in Ann Arbor,
we are looking for you as a(n) Senior Regulatory Affairs Specialist -FDA Medical.
Senior Regulatory Affairs Specialist-FDA Medical
  • Responsible for managing Wacker Chemical Corporation's corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
  • Responsible for refining Wacker's corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications.
  • Evaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
  • Prepars and submits forms and applications for Wacker FDA Drug and Device Master Files. Prepare portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation and preparing and submitting Medical Device Master File (MAF) packages and updates.
  • Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing.
  • Awareness of drug facility registration requirements would be useful. For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products.
  • Recognition of the differences between US and Canadian regulations. Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent
  • Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
  • Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG). Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process.

Requirements:
  • Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.
  • 7+ years of experience preferred.
  • Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
  • Strong leadership, interpersonal and problem-solving skills.
  • Experience working in cross-functional teams.
  • Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
  • Experience in polymer chemistry is preferred.

Apply