Regulatory CMC Expert

6 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €85,000 - €109,000
Regulatory CMC Associate Job

This is an exciting opportunity to join our team as a Regulatory CMC Associate. As a key member of our team, you will play a critical role in leading the global marketing authorization submission management processes.

Job Description:

We are looking for a highly skilled and motivated individual who can lead the various aspects of global marketing authorization submission management processes. You will partner with GRA-CMC RA Scientists to help create and manage submission content, provide guidance on structure and content placement within CTD registration submissions, and assist with submission-related Ministry of Health responses or Lilly affiliate questions.

Key Responsibilities:
  • Lead CMC submission management with knowledge of CMC regulatory requirements, ICH CTD, evolving global agency standards, CMC RA submission processes, electronic submission regulations and CTD structure guidance;
  • Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products;
  • Triage Lilly affiliate inquiries and, when needed, consult with the CMC RA Scientist to prepare responses;
  • Interpret global regulations and guidance and align submission processes and publishing standards with local regulatory requirements;
Requirements:
  • Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related field);
  • Knowledge of pharmaceutical drug development or industry-related experience preferred;
Benefits:
  • Diverse team environment with opportunities for growth and development;
  • Competitive compensation package and benefits;
  • Opportunities for professional advancement and career growth;
What We Offer:
  • A dynamic and collaborative work environment;
  • The opportunity to work with a talented team of professionals;
  • A comprehensive benefits package including health insurance, retirement plan, and paid time off;

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