Global Regulatory Affairs Specialist

6 days ago


Johannesburg, Gauteng, South Africa ICON Plc Full time
About the Role

As a Senior Global Regulatory Affairs Specialist at ICON plc, you will play a pivotal role in ensuring compliance with regulatory requirements and guidelines.

Your responsibilities will include coordinating central independent ethics committee submissions, communicating submission status updates, and providing regulatory information to sponsors and internal project teams.

You will be responsible for preparing core clinical trial applications, performing quality control on central submission packages, and supporting business development efforts by contributing regulatory input for proposals and bid defense meetings.

We are seeking an individual with a strong understanding of global regulatory requirements and guidelines, excellent communication skills in English, and the ability to work independently and collaboratively in a fast-paced environment.

In this role, you will have the opportunity to contribute to the advancement of innovative treatments and therapies, working closely with our diverse and dynamic team to design and analyze clinical trials.



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