Regulatory

Regulatory

At anytime, there are more than 300,000 clinical studies happening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector to protect public safety. The stringency of this regulation is evidenced by the fact that since the Food and Drug Administration (FDA) came into being in 1938, just 1,453 drugs have been approved, despite 7.3 million drugs being reviewed during clinical development.

The FDA has long been criticized for taking too long to approve new drugs so Congress passed legislation in the 90’s aimed at speeding up the entire process. In 2004, Merck withdrew its painkiller Vioxx after studies showed the pill increased the risk of heart attacks and strokes. In this instance the FDA was highly criticized for approving medicines too easily and for delaying issuing warnings about potential drug risks. Congress attempted to amend this, so in 2016 the 21st Century Cures Act was passed. The entire process took three years for Congress to pass it and its benefits have yet to be fully seen (statnews).

In order to achieve future growth the FDA could look to India as an example. The current rate of seven to eight percent CAGR growth is expected to lead to about $80bn to $90bn in sales by 2030. According to the Indian Pharmaceutical Association, simplifying regulatory approval processes is key for the sector to experience growth.

Technology is key for moving these regularity processes forward. Organizations such as the Regulatory Affairs Professionals Society (RAPS) explores the challenges and opportunities for the regulatory affairs sector of implementing digital health solutions, data safety and data risk in the digital healthcare sector and global digital drug information sources. TORPA: The Organization for Professionals in Regulatory Affairs also highlights how future talent in the industry will need to embrace new skills, such as data analytics, to improve the regulatory process in line with technological innovation in life sciences.

Regulatory Jobs

Director Global Regulatory Affairs
10% bonus scheme, Frankfurt (Oder)

Fantastic opening with one of the Global Leaders in the pharmaceutical space. This opportunity wi...

Apply now
Project Manager - Labelling
Negotiable, England

Project manager to lead a project in labelling across 3 different work streams. Experience across...

Apply now
Regulatory Affairs Manager
Negotiable, Newark

A clinical stage company located in the San Francisco Bay Area is looking for a Regulatory Affair...

Apply now
Associate Director, Regulatory Project Manager
Negotiable, Cambridge

Associate Director, Regulatory Project Manager Summary: A leading well-known life sciences compan...

Apply now
Sr. Manager, Regulatory Project Manager
US$130000 - US$150000 per annum, Cambridge

Sr. Manager, Regulatory Project Manager Summary: A leading well-known life sciences company speci...

Apply now
Director Regulatory Affairs
Company car,medical insurance,pension,33 days holiday, Frankfurt (Oder)

A Leading Cell & Gene therapy company based in Europe are now looking for an Associate Director t...

Apply now
Regulatory Strategy Director (remote)
Company Car, Medical Insurance, Pension, 33 days holiday, England

A Leading Cell & Gene therapy company based in Europe are now looking for an Associate Director t...

Apply now
QA on the Floor Specialist
Negotiable, Walkersville

Observation of critical manufacturing steps, clean room behavior and adherence to defined paramet...

Apply now
Regulatory Submissions Coordinator
Negotiable, Australia

An award-winning global full serviced Clinical Research Organisation with international reputatio...

Apply now