Regulatory Affairs

Department of Regulatory Affairs in Pharmaceutical Company and in Clinical Research Organisation is considered as one of the most important department. RA is one of the popular areas for job among job seekers. Job profile in RA includes product registration, dossier preparation, studying regulatory guidelines regarding product registration, import, export, and clinical trials from different countries. It also includes data management, regulatory filing, supervising the process to comply with the set guidelines.

Scope of Regulatory Affairs :

Launching a new drug is exhaustive work of pharmaceutical companies. Regulatory Affairs department is very often the first point of contact between the government authorities and the company. More important of this is regulatory affairs professionals who make documents for registration of new drugs from Regulatory authorities and help pharmaceutical companies for marketing authorisation of new products.

Career Prospects

• 1. Regulatory Affairs Professional in biotechnology, food science, pharmaceutical, nutraceutical, cosmeceutical
• 2. Clinical Research Organisation (CRO)
• 3. Hospitals
• 4. Government Agencies
• 5. Medical device sectors to keep track of changing legislation