Sr. Manager, CMC Regulatory Science

Sr. Manager, CMC Regulatory Science

Moderna

Basel, Switzerland

Here's What You’ll Do:

Your key responsibilities will be:

• Support development of 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.
• Contribute to the 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.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Provide interpretation of regulatory guidance documents, regulations, and directives – advise Manufacturing, Quality, and Process/Analytical Development groups regarding their applicability and impact on internal programs.

Your responsibilities will also include:

• Successfully managing multiple projects in a fast-paced environment.
• Collaborating effectively with cross-functional teams.
• Staying updated on regulatory changes and guidelines.

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

• Prioritize the platform: Ensuring that the regulatory strategies and submissions align with Moderna's overarching goals and priorities.
• Act with urgency: Managing multiple projects efficiently and ensuring timely submissions to regulatory authorities.

Here’s What You’ll Bring to the Table:

Minimum Qualifications:

• BA/BS degree in a scientific/engineering discipline.
• 6+ years of experience in the Pharmaceutical industry.
• Knowledge of current US and EU regulations and cGMP.
• Experience with CTD format and content regulatory filings.
• Exceptional written and oral communication.

Preferred Qualifications:

• BS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
• 8+ years of experience in regulatory in the pharmaceutical/biotech industry.
• 4+ years of experience in Regulatory CMC is desirable.

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Switzerland      Clinical Research      Manufacturing and Logistics      On-site      Regulatory Affairs      Moderna