CMC Regulatory Affairs Professional

vor 2 Monaten

Luzern, Luzern, Schweiz 1925 GlaxoSmithKline LLC Vollzeit

About the Role

The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

Key Responsibilities:

  • Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
  • Responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory & scientific standards.
  • Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications.
  • Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
  • Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
  • Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
  • Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
  • Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
  • Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Requirements

  • BS in a Life Sciences or related field.
  • Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
  • Two or more years of experience in drug development, manufacturing processes and supply chain and may have a specialized area of expertise.

Preferred Qualifications:

  • MS in a Life Sciences or related field.
  • RAPS Certification.
  • Biologics experience.
  • Veeva Vault experience.
  • Pre-approval experience (phase 1 to phase 3 submission experience).
  • Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

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