Requirements: English
Company: EPM Scientific
Region: Paris , le-de-France
The Regulatory Strategist will also act as Digital Subject Matter Expert to support Sanofi Digital initiatives. Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects Liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders in partnership with the GRL to enable successful regulatory outcomes Contributes to the development of global Health Authorities interaction strategy, attends and may lead Health Authorities meetings, and leads the team through meeting preparations Leads submission team or regulatory sub team to ensure regulatory filings meet the project timelines for product launch May lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation Supports operational and compliance activities for assigned regulatory deliverables and develops regulatory submission planning, including submission tracking in the electronic document management system Acts as Digital Subject Matter Expert in working groups to support Sanofi Digital initiatives Ability to work in electronic document management systems, e.g., Strong appetite for new technologies and digital trends, and ability to quickly adopt and master relevant digital tools Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred Demonstrated experience with US, EU and International activities (preparation of NMAs, LCM activities, EU/US briefing documents). Digital training and understanding on Sanofi Digital Transformation (AI role)