Job Description

The Role:
The Sr. Manager, CMC Regulatory Affairs will be based at the Basel site and will be responsible for preparing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead all regulatory activities to support high quality CMC sections of regulatory documentation.

Here’s What You’ll Do:
Develop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks

Provide guidance for regulatory CMC aspects of product development projects

Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines

Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions

Develop regulatory processes and procedures to support CMC components of regulatory submissions

Support the creation and maintenance of CMC submission templates

Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls

Provides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Here’s What You’ll Bring to the Table:
Minimum Qualifications

BA/BS degree in a scientific/engineering discipline

8+ years of experience in the Pharmaceutical industry

4+ years of experience in Regulatory CMC, including DMF/ASMF submissions

Strong knowledge of current US and EU regulations and cGMP

Strong experience with CTD format and content regulatory filings

Exceptional written and oral communication

Preferred Qualifications

M.S. degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable

12 years of experience in regulatory in the pharmaceutical/biotech industry

6+ years of experience in Regulatory CMC

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna\'s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna\'s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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