How to know about Regulatory Affairs in Pharma Industry.

·         Here we are discussing about important, role and posts of Regulatory Affairs.

·         Regulatory Affairs used to protect public health from the medicines.

·         IMPORTANTS OF REGULATORY AFFAIRS:

·         Identification of various regulatory options for drug development.

·         Optimising the products.

·         Speeding it means Time to Market strategic thinking.

·         Involvement in critical business functions.

·         Engagement in manufacturing site optimisation activities.

·         Regulatory expertise throughout the product lifecycle.

·         ROLE OF REGULATORY AFFAIRS:

·         Central involvement in development process.

·         Construction of core dossier (documentation).

·         Involvement in data management.

·         Local SOP’S control

·         Focus on complains (QA, GMP, CGMP).

·         Involvement in site inspections.

·         Involvement in audits.

·         Involvement in customer service issues.

·         Tie-up with Pharmacovigilance.

·         Regulatory intelligence

·         And finally publishing.

·         REGULATORY AFFAIRS POSTS (OR) JOBS:

·         Manager

·         Team leader

·         Team player

·         Project manager

·         Scientist

·         Diplomat

·         Negotiator

·         Strategist

·         Organiser

·         Seller.

·         REGULATORY AFFAIRS SUPPORTING STAFF’S ARE:

·         Technician

·         Technical writer

·         Document manager

·         Manufacturer

·         Editor

·         Professional reader

·         Information specialist

·         Expert

·         Philosopher.