Associate Director, Global Regulatory Science - CMC

Moderna

Basel, Switzerland

The Role

The Associate Director, Global Regulatory Science - CMC will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing global regulatory CMC strategies and collaborating with key stakeholders to align these strategies with regulatory requirements and business priorities.

Here's What You’ll Do

Your key responsibilities will be:

Developing and executing effective regulatory CMC strategies for global IND/CTA/BLA/MAA submissions.
Leading regulatory CMC discussions and interactions with Health Authorities to facilitate the review and approval process.
Providing regulatory CMC advice to manufacturing and quality teams and reviewing documents for submission readiness.

Your responsibilities will also include:

Identifying regulatory risks and crafting mitigation strategies.
Supporting the development of regulatory processes and advising on the impact of regulatory guidance on internal programs.
Assessing change controls related to quality and manufacturing changes to ensure compliance with regulatory standards.
Supporting the creation and maintenance of CMC submission tools and templates to enhance submission efficiency.
Providing interpretation of new regulatory guidance documents, regulations, and directives and advising Manufacturing, Quality, and Process/Analytical Development groups regarding their applicability and impact on internal programs.

The key Moderna Mindsets you’ll need to succeed in the role

Prioritize the Platform: You will be crucial in leveraging our technological platforms to accelerate drug development and regulatory approvals.
Act with Urgency: The ability to manage multiple projects and navigate a fast-paced environment will be key to maintaining progress and delivering results efficiently.

Here’s What You’ll Bring to the Table

BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required
8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
5+ years of experience in Biologics focused Regulatory CMC
Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions
Knowledge of current CMC regulations outside of the US, as well, is preferred
Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)
Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
Ability to work independently
Exceptional written and oral communication

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