Pharmaceutical Regulatory Consulting Education and Training

Careers in pharmaceutical regulatory consulting require knowledge of FDA regulations and continuing education

Pharmaceutical regulatory consultants assist drug manufacturers and biotech companies with activities related to the submission of new drugs to the Food and Drug Administration (FDA). Responsibilities of regulatory consultants include ensuring manufactures and companies adhere to FDA regulations, reviewing clinical studies, reports and documentation, coordinating communications with the FDA and other health authorities with product submissions and advising on product labeling.

To have a career working as a pharmaceutical regulatory consultant, one must:

1. Possess a life sciences degree such as biology and biochemistry.

2. Complete Pharmaceutical and Biotech Training.

3. Be familiar with FDA regulations, particularly 21 CFR Part 11.

 

Earn a life sciences degree to qualify for a career in clinical and regulatory affairs consulting

Individuals working for a clinical and regulatory affairs consulting company typically have a degree in life sciences, such as biology, biochemistry or botany, as well as knowledge of the drug development processes, Food and Drug Administration (FDA) regulations and current issues in the pharmaceutical industry. Pharmaceutical regulatory consulting services include providing guidance on the regulatory process for FDA submissions and training of staff.
Try: The University of Iowa offers a degree program in biology while the Colorado State University offers degrees in Biochemistry and Molecular Biology that will serve as a foundation for a career as a regulatory consultant.

Look for training courses for your pharmaceutical regulatory consulting education and training

Pharmaceutical regulatory consulting firms work to ensure drug manufactures are abiding by regulations and producing products that are safe and contain the ingredients (in the dosage amount) identified on packaging. Training to keep pharmaceutical regulatory consultants current in the field includes courses in Adverse Drug Events - Reporting and Regulatory Requirements, BioManufacturing of Protein Therapeutics: Rewards and Challenges, and Chemistry and Manufacturing & Controls (CMC) Regulatory Compliance for Biopharmaceuticals and Biologics. Pharmaceutical regulatory training also involves staying abreast of pharmaceutical regulatory compliances and pharmaceutical validation processes, such as Calibration in the FDA Regulated Industry, Pharmaceutical Quality Assurance and Control and U.S. FDA Regulatory compliance.
Try: The Center for Professional Innovation and Education and the Center for Professional Advancement offer Pharmaceutical Regulatory Compliance and Pharmaceutical & Biotech Training Courses.

Familiarize yourself with FDA regulations to train for pharmaceutical regulatory consulting

Individuals working for pharmaceutical and FDA regulatory consulting services must be knowledgeable with 21 CFR, particularly Part 11, which addresses the standards of electronic records and signatures. Like other industries, the pharmaceutical field is constantly evolving, requiring revisions to existing regulations or the legislation of new regulations. Pharmaceutical regulatory consultants must be up to date on topics such as the drug approval process and quality system compliance.
Try: FDA Regulatory markets books addressing FDA regulations and 21 CFR Part 11 Section 820.25 that refers to training requirements. Lab Compliance offers an online tutorial of 21 CFR Part 11 focusing on Electronic Records and Electronic Signatures.

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