About this Senior IA regulatory specialist role at Excelya
Join Excelya, where Audacity, Care, and Energy define who we are and the way we work.
We foster innovation, collaboration, and continuous growth in a stimulating and dynamic environment.
As an AI Regulatory Consultant, you will play a key role in transforming regulatory intelligence and monitoring activities by identifying opportunities offered by artificial intelligence and emerging technologies to optimize processes, strengthen regulatory foresight, and support strategic decision-making.
Key Responsibilities
- Conduct an assessment of the current regulatory intelligence and monitoring framework.
- Identify and analyze strategic regulatory sources (EMA, CMDh, ANSM, HMA, national authorities, regulatory publications and guidelines, etc.).
- Gather and formalize the needs of Regulatory Affairs teams.
- Evaluate optimization opportunities and automation potential within existing processes.
- Develop a regulatory intelligence strategy aligned with business challenges and operational activities.
- Design a framework for qualifying and prioritizing regulatory information.
- Assess the impact of regulatory changes on the company’s activities and product portfolio.
- Develop a methodology for contextualizing regulatory information according to product portfolios and target markets.
- Identify and evaluate artificial intelligence use cases applicable to Regulatory Affairs.
- Contribute to the assessment and selection of technology solutions available on the market.
- Critically evaluate proposed tools, technologies, and innovative approaches.
- Define how AI can be effectively integrated into regulatory processes and practices.
Requirements
- Education: Pharmacist, scientist, or holder of an advanced degree in Life Sciences. Additional training in digitalization, innovation, or transformation is highly valued.
- Experience: Proven experience in Pharmaceutical Regulatory Affairs, including the implementation of Regulatory Intelligence and/or Regulatory Excellence initiatives.
- Languages: Fluent in both English and French.
Benefits
Why Join Us?
At Excelya, we combine a passion for science with a strong enthusiasm for teamwork to redefine excellence in healthcare.
What makes us unique:
We are a young and ambitious healthcare company, bringing together 900 Excelyates, with the ambition of becoming the leading mid-sized CRO in Europe while delivering the best employee experience.
Our one-stop provider service model, offering full-service, Functional Service Provider (FSP), and consulting solutions, gives you the opportunity to grow through a wide variety of projects and assignments.
By working alongside recognized industry experts, you will contribute to advancing scientific, operational, and human knowledge, ultimately enhancing the patient journey.
“Excelling with Care” means thriving in an environment that values your natural talents, encourages bold thinking, and supports your professional development, empowering you to make a meaningful contribution to our shared mission.
