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Global Regulatory Expert
3 weeks ago
With precision and expertise, we deliver strategic solutions for the pharmaceutical industry. Our mission is to drive innovation through clinical trial execution, leveraging deep scientific knowledge and advanced data sciences.
Key Responsibilities- Lead cross-functional teams responsible for regulatory submissions worldwide, fostering a culture of excellence and collaboration.
- Develop and implement comprehensive regulatory strategies for clients and project teams, ensuring compliance and effectiveness.
- Establish clear operational objectives and assignments for assigned team members, empowering them to achieve success.
- Oversee and review applications to Regulatory Authorities, maintaining the highest standards of quality and integrity.
- Select, train, develop, coach, and manage the performance of Regulatory Managers, promoting growth and development within the organization.
- Represent Global Regulatory Affairs at project team meetings, effectively communicating key messages and managing regulatory workflow between departments.
The ideal candidate will possess extensive knowledge and experience in all aspects of drug development, including regulations and guidelines (such as NA, EMA, APAC, national authorities and ICH/GCP/GMP).
Apply your expertise and passion for regulatory affairs to make a meaningful impact in our organization.