Manager, Regulatory CMC - International - Visp

☞ Moderna

View: 140

Update day: 26-03-2024

Location: Visp Valais VS

Category: Legal / Contracts

Industry: Financial Services Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

The Role

The Manager of Regulatory CMC - International will be based in Basel, Switzerland and will be responsible for advising, preparing, and overseeing CMC and Quality related strategies compliant and optimized for the European and International countries. The Manager of Regulatory CMC - International will support Reg-CMC correspondence and regulatory applications, as well as support CMC submissions and regulatory compliance for the global development of the Moderna platform especially with a focus on EU and International countries. This position will support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients.

Here’s What You’ll Do
  • Support effective CMC regulatory strategies for submissions () 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
  • Support 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
  • MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
  • 6+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
  • 3+ years of experience in focused Regulatory CMC, preferably Biologics based
  • Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
  • Strong experience with CTD format and content regulatory filings
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Ability to work independently to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

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

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Deadline: 10-05-2024

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