Regulatory Intelligence Manager
4 weeks ago
Proclinical Group is seeking a Regulatory Intelligence Manager to support the Director of Regulatory Intelligence at a biotech company. This is a contract position. The role focuses on global monitoring and surveillance activities throughout the drug development lifecycle. The successful candidate will be responsible for implementing and managing Regulatory Affairs software, handling high-priority regulatory projects, and influencing policy and regulatory decision-making processes.
Key Responsibilities:
- Implement and manage Regulatory Affairs software for reviewing agency guidance and documentation.
- Manage high-priority regulatory projects, including Artificial Intelligence, submission management, and new industry guidelines.
- Understand the regulatory framework of ongoing procedures and applications in regional and global markets.
- Lead the collection, formatting, maintenance, and distribution of regulatory intelligence data and content.
- Build and maintain the Regulatory Intel SharePoint Site for report distribution.
- Maintain project plans and assigned responsibilities within the Regulatory Intel group.
Requirements:
- Proficiency in managing regulatory projects and software.
- Strong understanding of global regulatory frameworks and procedures.
- Ability to gather and analyze regulatory intelligence data.
- Excellent project management and organizational skills.
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Regulatory Intelligence Specialist
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Regulatory Intelligence Lead
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Regulatory Intel Manager
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Regulatory Affairs Strategist
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Regulatory Affairs Senior Manager EU
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