Regulatory Subject Matter Expert
hace 3 semanas
Location: Barcelona
Day Rate: €500
TechNET-IT is working with a leading organisation in the global pharmaceutical and biotechnology industry, currently seeking a Regulatory Subject Matter Expert (SME), Data & AI to join their dynamic team. This is an exciting opportunity to play a crucial role in ensuring compliance with regulatory requirements while leveraging data and AI in the development of life-changing therapies.
Key Responsibilities:
Regulatory Guidance: Provide expertise on global regulations and guidelines (FDA, EMA, MHRA) related to the use of data and artificial intelligence in pharmaceutical research, development, and commercialisation.AI & Data Compliance: Ensure AI models, machine learning algorithms, and data governance processes adhere to regulatory and ethical standards.Cross-Functional Collaboration: Work closely with data science, IT, clinical, and regulatory teams to ensure seamless integration of AI and data strategies in drug development and patient safety processes.Regulatory Submissions: Support the preparation and review of regulatory submissions that involve AI-driven processes or data use.Monitoring & Reporting: Keep abreast of changes in regulatory requirements related to data and AI, and ensure compliance with evolving standards.Risk Management: Identify potential compliance risks related to AI and data use, and propose mitigation strategies.Handover & Training: Collaborate with internal teams to ensure understanding and adherence to regulatory requirements and best practices for data and AI use.Key Requirements:
Experience in Regulatory Affairs: Proven experience in regulatory roles within the pharmaceutical, biotech, or healthcare industry, particularly with a focus on drug development, clinical trials, and regulatory submissions.AI & Data Knowledge: Solid understanding of data science, machine learning, and AI technologies, particularly as applied to pharmaceuticals or healthcare.Educational Background: Degree in life sciences, regulatory affairs, data science, computer science, or a related field. Additional certifications in regulatory affairs and/or AI/data governance would be an advantage.Pharmaceutical Experience: Previous experience working in large-scale pharma, biotech, or healthcare companies, particularly in projects involving AI and data.Regulatory Expertise: Deep knowledge of international regulatory frameworks (FDA, EMA, MHRA, GDPR, etc.) and compliance standards related to AI and data usage.Strong Communication Skills: Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.Problem-Solving Ability: Skilled in identifying and addressing regulatory challenges in AI and data initiatives.What's on Offer:
Competitive salary and benefits packageThe opportunity to work with cutting-edge AI and data technologies in a fast-growing, innovative pharmaceutical/biotech environmentCollaboration with cross-functional teams on impactful projects shaping the future of drug developmentIf you have a passion for ensuring compliance in the rapidly evolving intersection of data, AI, and pharmaceuticals, we'd love to hear from you
TechNET-IT is assisting this client in their search for a top candidate. If you're interested in this position, please apply directly or contact us for more information.
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