How do I get experience in regulatory affairs?
A detailed account of these basic steps follows.
- Step 1: Earn a bachelor’s degree (four years).
- Step 2: Get practical experience in the field (one to four years).
- Step 3: Complete advanced coursework in regulatory affairs (one to five years).
- Step 4: Obtain certification (several weeks or months).
What is Regulatory Affairs pharmacovigilance?
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
What is a regulatory affairs job?
Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies.
What does a pharmpharmacovigilance professional do?
Pharmacovigilance professionals are qualified drug safety specialists. One particular area of their work includes performing a lot of functional responsibilities like safety trend analysis, maintaining adverse reaction data, keeping global safety databases updated and conducting safety training.
What is the relationship between medical affairs and Regulatory Affairs?
Some background in regulatory affairs is also expected of medical affairs professionals. Medical affairs and regulatory affairs are two departments that work very closely with each other.
What is the scope of Medical Affairs?
Medical Affairs professionals are engaged in projects such as medical literature production, medical consulting, designing clinical trials, providing medical support to ongoing studies etc. Health care companies often hire people who have relevant experience in regulatory affairs but experience is not always essential.