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

Print Services Coordinator
US$35 - US$40 per hour, Hawthorne

Print Services Coordinator 3 month contract Onsite in Hawthorne, NY $35-40/hr/W2 Summary: A pharm...

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Manager, Regulatory Operations
Negotiable, Massachusetts

Contract-to-Hire Regulatory Operations Manager - 100% Remote 6 Month Contract-to-Hire My client i...

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Regulatory Specialist
Negotiable, California

Contract Regulatory Specialist - 100% Remote One Year Contract My client in the pharmaceutical in...

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Senior Regulatory Affairs Specialist/Specialist (Remote)
Negotiable, Cincinnati

A global Medical Device Manufacturing company, based out of Ohio is looking to add a Senior Regul...

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Associate Director, Global Regulatory Affairs
Negotiable, Boston

A global Biotechnology Research company is looking to bring on an Associate Director Global Regul...

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Regulatory CMC Manager
Negotiable, Singapore

Title: Regulatory CMC Manager Location: Singapore Overview: One of the leading global biotech is ...

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Sr. Manager, Regulatory Affairs
Negotiable, New York

A Generic Pharmaceutical company with a global outreach is looking for a driven Regulatory Affair...

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Freelance Scientific Writer
Negotiable, Netherlands

EPM Scientific are partnered with a global biopharmaceutical company who are currently seeking a ...

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Document Control Specialist
Negotiable, Andover

Responsibilities: Implement electronic file system and integrity of all Company documents Executi...

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