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Associate Director, Global Regulatory, CMC at Moderna - ApplyBlast

Associate Director, Global Regulatory, CMC

Moderna

5 months ago

3.2 on Glassdoor

Norwood, Massachusetts

Hybrid

Full Time

Senior

0 applicants

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About this role

The Associate Director, Global Regulatory-CMC at Moderna develops and implements global regulatory strategies for complex biopharmaceutical products throughout their lifecycle. This role involves coordinating CMC activities, managing agency interactions, and ensuring submission readiness for health authorities while guiding cross-functional teams on manufacturing and quality regulations.

Responsibilities

Develop and implement global CMC regulatory strategies for product submissions
Lead regulatory discussions with health authorities to facilitate approval
Review documentation for submission readiness and guideline compliance
Assess manufacturing change controls and evaluate regulatory impacts
Mentor product teams on CMC and Quality-related agency correspondence

Skills

Qualifications

Bachelor's or Master's in Molecular Biology, Pharmaceutics, Chemistry, or Chemical EngineeringPhD in related scientific 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.