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Executive Director, CMC Regulatory Science at Moderna - ApplyBlast

Executive Director, CMC Regulatory Science

Moderna

5 months ago

3.2 on Glassdoor

Norwood, Massachusetts

Hybrid

Full Time

Senior

0 applicants

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About this role

A Regulatory CMC Leader at Moderna manages a team of experts to oversee regulatory strategies and documentation for all therapeutic area products. The role involves leading submissions, interfacing with health authorities, and developing processes to ensure high-quality CMC sections in regulatory filings. This position requires aligning CMC strategies with company needs while delivering clear communication to leadership and manufacturing teams.

Responsibilities

Lead a team to develop and implement CMC regulatory strategies for submissions
Review documents for submission readiness against health authority guidelines
Lead regulatory discussions and interactions with health authorities
Develop regulatory processes and procedures to support CMC components
Provide CMC regulatory expertise to manufacturing and quality teams

Skills

Qualifications

MS in Scientific DisciplinePhD in Scientific Discipline10+ Years Pharmaceutical Industry Experience8+ Years Regulatory CMC ExperienceStrong Knowledge of US and EU Regulations

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.