Healthcare Regulatory Specialist

10 hours ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
About the Opportunity

We have an exciting opportunity for a Senior Associate, Regulatory Affairs, CMC who is passionate about advancing therapeutics against life-threatening diseases. In this role, you will provide CMC regulatory support for new marketing applications and post-approval regulatory filings across international regions.

As a key member of our Regulatory Affairs team, you will work closely with Pharmaceutical Development, Analytical, Manufacturing and QA teams to assist and support the preparation of Quality sections for new marketing authorization applications, post-approval variations, renewals and responses to agency questions.

You will have the opportunity to contribute to global CMC regulatory strategies for International markets and liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.

Our company culture values teamwork, personal and professional development, and a friendly and supportive atmosphere. We encourage active learning and growth, and our employees are our greatest asset as we work to achieve our bold ambitions.

Estimated salary: £65,000 - £85,000 per annum depending on experience.



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