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

Associate Director, Global Regulatory Affairs, CMC

Moderna

1 month ago

3.2 on Glassdoor

Norwood, Massachusetts, United States

Onsite

Full Time

Director

0 applicants

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About this role

Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC to lead and support regulatory activities for the development of global products. This role focuses on preparing and overseeing CMC and Quality related agency correspondence, governing CMC submissions, and providing regulatory compliance support. The position requires managing multiple projects in a fast-paced environment to deliver transformative medicines to patients.

Responsibilities

Develop and implement CMC regulatory strategies for international submissions
Lead regulatory discussions and interactions with health authorities
Review documents for submission readiness and ensure regulatory compliance

Skills

Qualifications

BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related fieldMS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

About Moderna

modernatx.com

Headquarters

Cambridge, Massachusetts, United States

Company Size

1001-5000 employees

Founded

2010

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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.