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Associate Director, Global Regulatory Science, CMC at Moderna - ApplyBlast

Associate Director, Global Regulatory Science, CMC

Moderna

4 months ago

3.2 on Glassdoor

London, England

Hybrid

Full Time

Director

0 applicants

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About this role

Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC to lead regulatory activities and develop CMC strategies for international submissions in Basel. This pivotal role involves guiding product development projects, ensuring compliance, and overseeing the preparation of critical regulatory documentation for transformative mRNA medicines. The incumbent will lead CMC discussions with health authorities and provide comprehensive guidance across various therapeutic areas including vaccines and oncology.

Responsibilities

Develop and implement CMC regulatory strategies for international submissions
Lead regulatory discussions and interactions with health authorities
Oversee multiple programs and evaluate CMC change controls
Ensure compliance with EU and ROW regulations
Provide comprehensive regulatory guidance for various therapeutic areas

Skills

Qualifications

BS in Pharmaceutics or ChemistryMS in Pharmaceutics or Chemistry10+ years pharmaceutical experience8+ years Regulatory CMC experience

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.