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Regulatory and Start-Up Specialist
hace 2 meses
At Precision for Medicine, we're pushing the boundaries of what's possible in the life sciences. As a Regulatory and Start-Up Specialist, you'll play a critical role in helping us bring life-changing therapies to patients faster, cheaper, and with greater success. Your expertise will be key in integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. In this role, you'll be responsible for delivering site activation readiness within assigned countries/sites, foreseeing and mitigating risks, and preparing clinical trial applications and submission dossiers for submission to regulatory authorities. You'll also interact with regulatory agencies, provide regular updates, and maintain project plans, trackers, and regulatory intelligence tools.
Key Responsibilities- Prepare and submit clinical trial applications and dossiers to regulatory authorities
- Interact with regulatory agencies and handle responses
- Provide regular updates to project teams and stakeholders
- Maintain project plans, trackers, and regulatory intelligence tools
- Regulatory expertise and knowledge of clinical trial regulations
- Strong communication and project management skills
- Ability to work in a fast-paced environment and meet deadlines
This is an exciting opportunity to join a dynamic team and contribute to the growth and success of Precision for Medicine. If you're passionate about regulatory affairs and clinical trials, we encourage you to apply.
