Global CMC Regulatory Science Lead

BioSpace; Greater Lincolnshire; On-site; GBP 120,000 - 170,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family building benefits

Generous PTO

Savings and investments

Job summary

Moderna in Harwell, UK is seeking an Associate Director, CMC Regulatory Science-International to lead global CMC regulatory strategy, prepare and oversee agency correspondence, and govern regulatory submissions for mRNA products. You will manage multiple projects in a fast-paced environment and provide guidance to manufacturing and quality teams.

The role requires a strong track record in biologics-focused regulatory CMC, extensive experience with EU/ROW regulations, and a proactive,

Qualifications

• 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.
• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

Responsibilities

• 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.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
• Provide 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)

Skills

CMC Regulatory Strategy

Regulatory Submissions

Cross-functional Collaboration

Health Authority Liaison

Education

MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

Tools

CTD regulatory filings

Job description

Moderna in Harwell, UK is seeking an Associate Director, CMC Regulatory Science-International to lead global CMC regulatory strategy, prepare and oversee agency correspondence, and govern regulatory submissions for mRNA products. You will manage multiple projects in a fast-paced environment and provide guidance to manufacturing and quality teams.

The role requires a strong track record in biologics-focused regulatory CMC, extensive experience with EU/ROW regulations, and a proactive,