Global Regulatory Affairs

Join Our Trailblazing Team as Global Regulatory Affairs at Quris.ai (Part-time position)

At Quris.ai, we're at the forefront of integrating artificial intelligence with biotechnology to redefine predictive analytics in drug efficacy and safety. Our pioneering Bio-AI Clinical Prediction Platform is setting new benchmarks in the pharmaceutical industry, offering insights aiming to drastically reduce the costs and dependencies associated with traditional clinical trials and animal testing. With our operations spanning pharmaceutical services, consumer services, and drug discovery, our platform garners the interest of top-tier pharmaceutical companies worldwide.

As we extend our revolutionary scientific breakthroughs and technology, previously available only to leading pharmaceutical companies, to high-net-worth individuals through our Quris.life brand, we're offering cutting-edge longevity solutions. We're searching for Global Regulatory Affairs to join our leadership team. This role is a unique opportunity to play a pivotal part in shaping our company's direction from the ground up, from day to day, hands-on tasks throughout strategic marketing leadership and insights.

Responsibilities:

• Prepare regulatory documents such as correspondence, memoranda, and reports on regulatory matters.
• Analyse regulatory documentation of existing and potential contractors and partners
• Review USA clinical trial synopsis and integrate with the sponsor the effort of composing the full protocol and study documents in a timely manner
• Interact with and strategize process improvement with senior management.
• Implement best practices for GCP aspects.
• Resolve escalated regulatory issues and deliver difficult messages confidently.
• Review initiatives, manage team workload, and educate stakeholders on the regulatory process.
• Provide CMC input into Regulatory Development Plans.
• Communicate with regulatory authorities for feedback.
• Maintain knowledge of the regulatory environment in target geographies and contribute to shaping future regulatory environments.
• Contribute to label reviews, marketing and promotional materials approval.
• Collaborate with cross-functional teams to ensure compliance.
• Establish standard operating procedures and regulatory affairs.
• Lead Regulatory Strategy Document reviews for complex projects
• Develop and execute risk assessment analysis, contingency plans for registration and product lifecycle management issues.
• In case required - lead a local IRB approval process for the storage and/or research of patients IPSCs
• Similarity (the item #2) for the research activity in London
  
  

• Master’s Degree in Science, Pharmacology, Chemistry Or MD, or PhD.
• Minimum of 5 years of industry experience in Regulatory Affairs.
• Familiarity with new and emerging regulations.
• Experience in managing and leading discussions and dossier submissions to regulatory authorities.
• Knowledge of Clinical Trials (Good Clinical Practices) and Pharmacovigilance.
• Proficient in English (spoken and written).
• Excellent communication skills.
• Strong relationship-building skills.
• Ability to work independently and across the organization .