Regulatory Specialist and Senior Specialist

3 weeks ago


Maidenhead Berkshire, United Kingdom SRG Full time

SRG are currently looking for Regulatory Specialist for a Global Pharmaceutical Company who have opened new vacancies within their Regulatory team on an initial 12 Month basis to be based at their office in Maidenhead/Remote.
The Regulatory Specialist is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.
as well as operational support for Regulatory submission preparation and processing of amendments.
Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
Ensure all relevant databases and activity trackers are populated within agreed timelines.
Undertake all necessary training in order to achieve compliance with internal/external processes.
Comply with the company’s policies and procedures.
Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
At least 2-years CTA experience in global clinical trial submissions to regulatory agencies.
Experience working effectively across cultures and in a complex matrix environment.
Good Information Technology skills, proven ability to utilise a variety of computer application packages.
fluency in English.



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