Associate Director, Cmc Regulatory Science

Vor 2 Tagen

Basel, Schweiz Moderna Vollzeit

**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._

  • Associate Director, Regulatory Affairs Cmc

    Vor 5 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...

  • Associate Director/Director, Drug Product

    vor 1 Woche

    Basel, Schweiz Monte Rosa Therapeutics Vollzeit

    Overview Monte Rosa Therapeutics (MRT) seeks to recruit an Associate Director/ Director Drug Product CMC to play a key role in advancing our drug product development programs from early-stage development through commercialization. The successful candidate will join the CMC group supporting Monte Rosa’s portfolio of molecular glue degraders (MGDs) that...

  • Associate Director/Director, Drug Product

    vor 1 Woche

    Basel, Schweiz Monte Rosa Therapeutics Vollzeit

    Overview Monte Rosa Therapeutics (MRT) seeks to recruit an Associate Director/ Director Drug Product CMC to play a key role in advancing our drug product development programs from early-stage development through commercialization. The successful candidate will join the CMC group supporting Monte Rosa’s portfolio of molecular glue degraders (MGDs) that...

  • Associate Director, Cmc Regulatory Affairs

    Vor 2 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Manager, Regulatory Science, Cmc

    Vor 5 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here’s What You’ll Do**: - Support 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 -...

  • Associate Director Cmc of Technical Development

    Vor 2 Tagen

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are currently looking for an Associate Director CMC of Technical Development to join a brilliant biotech organisation on a permanent basis located in Basel. Our client is focused on producing the next generation of multifunctional accuracy immunotherapies. Please note that to be considered for this role you must have the right to work in this...

  • Ra Cmc Associate Manager

    Vor 5 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an **Regulatory Affairs CMC Manager** **for 18 month contract role based in Basel, Switzerland.** As Associate Manager within our Global Regulatory Affairs CMC team, you...

  • Associate Director/Director, Drug Product

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Monte Rosa Therapeutics, Inc Vollzeit

    OverviewMonte Rosa Therapeutics (MRT) seeks to recruit an Associate Director/ Director Drug Product CMC to play a key role in advancing our drug product development programs from early-stage development through commercialization. The successful candidate will join the CMC group supporting Monte Rosa's portfolio  of molecular glue degraders (MGDs) that...

  • Global Regulatory Cmc Lead

    Vor 2 Tagen

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC...

  • Regulatory Affairs

    vor 3 Wochen

    Basel, Schweiz Michael Page Vollzeit

    Regulatory Affairs - CMC (d/f/m) Michael Page is seeking a Regulatory Affairs CMC professional to support Phase 3 development activities for a globally renowned pharmaceutical company in Basel. The contract duration is 12‑24 months for candidates with 5+ years of relevant experience at various seniority levels. Depending on performance, the role...