Global Regulatory CMC Project Lead

2 semanas atrás


Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro
Job Summary

We are seeking an experienced Regulatory CMC Manager to join our team in Portugal. As a key member of our global operations, you will play a pivotal role in overseeing and coordinating Regulatory CMC activities to support tech transfer projects.

Key Responsibilities:
  • Develop and Implement Global CMC Strategies: Design and execute comprehensive regulatory strategies to meet diverse global requirements across production sites.
  • Manage Regulatory CMC Activities: Oversee the preparation, submission, and management of CMC documentation for regulatory filings.
  • Coordinate Change Notifications: Manage change notifications to ensure timely and accurate regulatory updates across global markets.
  • Stakeholder Collaboration: Build and maintain strong relationships with internal and external stakeholders, including regulatory agencies, supply chain teams, and manufacturing sites.
  • Support Tech Transfers: Align Regulatory CMC activities with tech transfer processes, ensuring smooth transitions while maintaining compliance.
Requirements:
  • Proven expertise in Regulatory CMC in a global environment, including regions such as Asia, LATAM, USA, and EU.
  • Strong understanding of CMC regulatory requirements for pharmaceuticals, particularly solid dosage forms.
  • Experience managing regulatory submissions and handling change control processes.
  • Excellent communication and organizational skills to facilitate collaboration across cross-functional teams.
  • Ability to manage complex projects and adapt plans to address unforeseen challenges.
What We Offer:
  • A competitive salary of €60,000 - €80,000 per year, depending on experience.
  • An opportunity to lead high-impact global projects in a collaborative environment.
  • Flexibility to work remotely, offering a healthy work-life balance.
  • A chance to work with a global organization committed to innovation and patient-focused solutions.

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