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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 will develop and execute regulatory strategies for biologics across the product lifecycle, ensuring alignment with global health authority guidelines. This role involves managing complex submissions, guiding cross-functional teams on manufacturing and quality compliance, and interpreting regulatory directives to support drug development.

Responsibilities

Develop global CMC regulatory strategies for product submissions
Guide cross-functional teams on compliance and manufacturing changes
Lead interactions with health authorities to secure approvals
Review documentation for submission readiness and guidelines adherence
Support the creation and maintenance of regulatory submission templates

Skills

Qualifications

BS/MS/PhD in Molecular BiologyBS/MS/PhD in PharmaceuticsBS/MS/PhD in ChemistryBS/MS/PhD in Chemical Engineering

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.