Principal Scientist

3 weeks ago

Limerick, Limerick, Ireland CareerWise Recruitment Full time

Job Title: Principal Scientist: Global Regulatory Affairs (CMC)

A key role has become available for a Principal Scientist to lead our company's regulatory affairs in the area of CMC development, providing strategic direction and guidance on global clinical trials, market registrations, and post-approval submissions. The successful candidate will have a strong understanding of global regulations, guidelines, and technical knowledge of CMC development and manufacturing processes.

Key Responsibilities:

  • Oversight of preparation and documentation of specified regulatory submissions
  • Regulatory leadership and direction for products listed as primary responsibilities
  • Development, planning, and execution of appropriate regulatory strategies and priorities through effective partnership with other departments
  • Management of submission timelines, monitoring approval status, and communication of change status to interested personnel
  • Good understanding of existing and emerging pharmaceutical & biotech-related regulations
  • Provision of necessary CM&C commitment information to site personnel
  • Ensuring compliance of GMP documents to regulatory commitments and support for batch release process
  • Review and/or approval of regulatory changes, proposals for reprocessing, validation, and stability protocols
  • Participation in Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives
  • Participation in industry association meetings and Client groups to benchmark and influence revisions to guidance

Requirements:

  • Bachelor's degree in sciences discipline required (e.g., chemistry, biology, biochemistry or pharmacy or related scientific discipline)
  • Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function
  • Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered
  • Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing
  • Good attention to detail and demonstrated effective teamwork skills
  • Proven ability to effectively influence within and beyond the organization

About Us: Our client is a start-up Biopharmaceutical company based in Limerick, Ireland, seeking a talented individual to join their team as a Principal Scientist in Global Regulatory Affairs.

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