Associate Director, Cmc Regulatory Science
Vor 2 Tagen
**The Role**:
**Here’s What You’ll Do**:
- Develop/implement effective CMC regulatory strategies for global 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
- Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Support the development of 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
- Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)
**Here’s What You’ll Bring to the Table**:
- MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 8+ years of experience in Biologics focused Regulatory CMC
- Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
- Strong knowledge of current EU and ROW regulations
- Strong knowledge of cGMP
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
**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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