天津招聘

职位描述：
POSITION SUMMARY
A Regulatory professional who contributes to drug development, as part of the Regulatory Affairs team, through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing applications and post approval support

Manager Regulatory Affairs is Regulatory professional who will have prior experience with several areas of Regulatory affairs (CTA/IND/ MAA) and the ability to lead internal teams and carry out regulatory activities and submissions independently

May work as part of a regulatory or cross-functional team depending on the size and nature of project

Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices

REQUIREMENTS
Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualification.
A minimum of 5 years experience in Regulatory affairs in the pharmaceutical or pharmaceutical contract service industry.
Being an active member of the Regulatory and ICON teams:
Actively participate in project (CT) team meetings
Effectively contribute to sponsor or internal projects (e.g. reg intel, process reviews etc.), by delivering on time to the expected quality standards and challenging the status quo, when appropriate.
Ability to work to procedures and propose improvements when appropriate.
Curious and willing to ask questions
Identify issues and proactively seek advice
Have ability to explain regulatory requirements 举报 分享

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.