Regulatory Affairs Leader
22 hours ago
Precision Medicine Group is a leader in the life sciences industry.
We integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
- Strong focus on Oncology and Rare Disease.
The Director Regulatory Affairs will provide leadership of teams responsible for regulatory submissions worldwide.
Key responsibilities include:
- Providing strategic, technical, and regulatory guidance to clients and team members.
- Establishing operational objectives and assignments for assigned team members.
- Tracking and reporting regulatory function metrics and key performance indicators.
- Oversighting regulatory submissions to authorities, including INDs/CTAs and amendments.
- Selecting, training, developing, coaching and managing the performance of Regulatory Managers.
Requirements:
- Bachelor's Degree or equivalent experience in a scientific or healthcare discipline.
- 10+ years relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry.
- Broad knowledge and experience of all aspects of drug development process.
This role offers numerous benefits:
Please note that this job description provides a comprehensive overview of the responsibilities and requirements.
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