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Global Regulatory Project Coordinator
il y a 1 semaine
Job Summary
We are seeking an experienced Regulatory Project Manager to join our dynamic Regulatory Affairs team. As a key member of our team, you will be responsible for planning, managing, and overseeing global regulatory submission activities across the product lifecycle.
About the Role
The successful candidate will have expertise in global submission planning, cross-functional team leadership, experience with rare disease and biological development, and a strong background within the biotechnology or pharmaceutical industry.
Key Responsibilities:
- Develop and execute comprehensive global regulatory submission plans for investigational and marketing applications (e.g., IND, NDA, BLA, MAA) in collaboration with cross-functional teams.
- Manage timelines, resources, and deliverables to ensure on-time submission and regulatory compliance.
- Coordinate and lead cross-functional project teams, including regulatory, clinical, quality, and manufacturing teams, to deliver high-quality regulatory submissions.
- Serve as the primary point of contact for health authorities and regulatory agencies, ensuring clear communication and compliance.
- Maintain project documentation, track progress, and prepare status reports for senior management and stakeholders.
What We Offer
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
