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Manager, Global Regulatory Science CTA at Moderna - ApplyBlast

Manager, Global Regulatory Science CTA

Moderna

4 months ago

3.2 on Glassdoor

Warsaw, Poland

Hybrid

Full Time

Senior

0 applicants

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About this role

This role leads the operational execution of Clinical Trial Applications (CTAs) globally outside the United States, with a specific focus on serving as Moderna's subject matter expert for the United Kingdom regulatory landscape. The position involves driving submission excellence, ensuring regulatory compliance, and managing interactions with Health Authorities across multiple development programs and regions. You will act as a key partner to global regulatory leads and clinical teams to enable the timely advancement of innovative mRNA medicines to patients.

Responsibilities

Lead global Clinical Trial Application activities outside the US framework
Serve as subject matter expert for UK clinical trial regulatory landscape
Coordinate and oversee Contract Research Organizations for CTA deliverables
Manage sponsor-side administration within regulatory platforms like CTIS and Veeva
Monitor adherence to global CTA processes and regulatory commitments

Skills

Qualifications

Bachelor's degree in life science or related disciplineKnowledge of Regulation (EU) 536/2014Experience with UK Clinical Trial Application requirements

About Moderna

modernatx.com

Headquarters

Cambridge, Massachusetts, United States

Company Size

1001-5000 employees

Founded

2010

View Profile

Moderna is a biotechnology company that is pioneering the use of mRNA technology to develop transformative medicines and vaccines. It gained global prominence for its COVID-19 vaccine, which showcased the potential of mRNA in rapidly addressing public health emergencies. The company is focused on creating innovative therapies to treat a range of diseases, advancing its product pipeline, and exploring new career opportunities in the biotech field. With a commitment to changing the landscape of medicine, Moderna is at the forefront of scientific research and development.