Regulatory Affairs Manager for Biologics

11 hours ago


Stockholm, Stockholm, Sweden Planet Pharma Full time
Senior CMC Professional Wanted for Biologics Development

We are seeking a highly skilled Senior CMC Professional to join our team at Planet Pharma. As a key member of our biologics development team, you will contribute to the development of innovative treatments and therapies.

Key Responsibilities:
  • Project Management: Manage multiple projects simultaneously, ensuring timely delivery and high-quality results.
  • Regulatory Compliance: Ensure all projects comply with relevant regulations and guidelines.
  • CMC Strategy Development: Develop and implement effective CMC strategies for our biologics pipeline.
  • Tech Transfer Expertise: Oversee technical transfers to ensure seamless integration of new technologies.
  • Collaboration and Communication: Build and maintain strong relationships with internal stakeholders and external partners.
Requirements:

To succeed in this role, you will need:

  • Proven Project Management Experience: Demonstrated ability to lead complex projects and teams.
  • Regulatory Knowledge: In-depth understanding of US and EU CMC regulatory requirements.
  • Technical Transfer Expertise: Experience with technical transfers and managing complex development and manufacturing processes.
  • CDMO Management: Previous experience managing CDMOs for outsourced manufacturing is highly desirable.
  • Biologics Manufacturing: Experience in biologics manufacturing is essential.


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