Sr. Director, Cmc Regulatory Science

vor 2 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
**Here’s What You’ll Do**:
Lead a team to develop/implement effective CMC regulatory strategies for submissions
(e.g. IND/CTA/BLA/MAA) and identify regulatory risks

Provide expertise for regulatory CMC aspects of product development projects

Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the company

Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level

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

Support the creation and maintenance of CMC submission templates

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

Provides interpretation of domestic and international regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.

Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully

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

MS/PhD degree in a scientific/engineering discipline

10+ years of experience in the pharmaceutical/biotech industry

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

Strong knowledge of current EU and ROW regulations

Strong experience with CTD format and content regulatory filings

Exceptional written and oral communication

Preferred Qualifications

MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable

10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

8+ years of experience in Biologics focused 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 is a smoke-free, alcohol-free and drug-free work environment.

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