
Regulatory Affairs Manager for Biologics
11 hours ago
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.
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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