The main functions and tasks of a Regulatory Affairs position

A

anaidagf

#1
Hi,

Please, can someone explain to me the main funtions and tasks of a Regulatory Affair position?

Regards,
Anaida
 
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ScottK

Not out of the crisis
Leader
Super Moderator
#2
Re: Regulatory Affair

Hi,

Please, can someone explain to me the main funtions and tasks of a Regulatory Affair position?

Regards,
Anaida
Hi Anaida, welcome to the Cove.
The exact job descriptions will vary from company to company but in General a Regulatory Affairs person is the person that is responsible for:
  • Understanding the regulations that the company is subject to
  • Championing the compliance to the regulations
  • Updating company documents to reflect compliance with current regulations
  • Training co-workers an employees in the regulations
  • Performing audits of the QMS to the regulations
  • Representing the company in front of the regulatory body during an inspection
 
J

JanWarner

#3
Re: Regulatory Affair

Dear anaidagf,

There are some differences for each company, but a Regulatory Affiars person is the person in a regulated industry. (Food, Drug, Medical Device etc) that translates the myriad of regulatory guidelines and requirements into strategic and tactical plans and solutions to legally market, sell and ship these products. The regulatory person also deals with Global and Local requirements for labeling, filing, licensing, approval and
shipping these regulated products. This person may at times communicate with regulatory bodies in order to seek clarification of laws and guidelines. Finally, the regulatory person works as a team with QA, QC, Production/Manufacturing, Marketing and Sales to meet their requirements.
 
A

anaidagf

#5
Re: Regulatory Affair

Dear anaidagf,

There are some differences for each company, but a Regulatory Affiars person is the person in a regulated industry. (Food, Drug, Medical Device etc) that translates the myriad of regulatory guidelines and requirements into strategic and tactical plans and solutions to legally market, sell and ship these products. The regulatory person also deals with Global and Local requirements for labeling, filing, licensing, approval and
shipping these regulated products. This person may at times communicate with regulatory bodies in order to seek clarification of laws and guidelines. Finally, the regulatory person works as a team with QA, QC, Production/Manufacturing, Marketing and Sales to meet their requirements.
Thank you very much for this useful information.
 
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