Role of Regulatory Affairs Professionals

Regulatory Affairs Professionals usually have responsibility for the following general areas:

1. Act as a representative of company to the regulatory authorities to comply effectively all the regulatory issue of business.

 
2. Regulatory personnel ensure that their companies comply with all of the regulations and laws pertaining to their business.

3. Directly face with federal, state and local regulatory agencies and personnel on specific issues i.e. US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency (PMDA), CDSCO (India), Health Canada.

4. To maintain and handle the company regulatory (GMP, GCP, ISO) audit by government authority or other external authority.

5. To prepare and submit dossier for regulatory approval in research and development phases, clinical trials, manufacturing, labelling and advertising and post market surveillance in format specified by guidelines of respective authorities.

6. Advising company on the current regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs.