Our client is a biopharmaceutical company with a mission to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases.
The Regulatory Operations Manager oversees the operational aspects of regulatory submissions and compliance, ensuring accurate, timely, and compliant preparation and submission of regulatory documents to global agencies. They also manage the regulatory infrastructure, liaise with internal and external stakeholders, and maintain current knowledge of regulations.
Key Responsibilities:
Submission Management:
Infrastructure Management:
Regulatory Knowledge:
Collaboration:
Project Management:
Process Improvement:
Data Management:
Risk Assessment:
Skills and Qualifications:
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