Requirements: English
Company: EPM Scientific
Region: Paris , le-de-France
Main Responsibilities As a key member of the GlobalRegulatory Team, the Regulatory Strategist (RS) is a strategicpartner in defining and executing global regulatory strategies forassigned products, ensuring successful implementation across US,EU, and worldwide markets, including Health Authority interactions.The Regulatory Strategist will also act as a Digital Subject MatterExpert to support digital initiatives. - Enables the GlobalRegulatory Lead (GRL) by providing quality regulatory input andguidance to internal stakeholders, including clinical development,commercial teams, and the Global Regulatory Team for assignedprojects. - Collaborates with clinical, medical, commercial, andsupply teams to drive regulatory success in partnership with theGRL. - Contributes to regulatory strategy development byparticipating in governance committees and forums. May representthe Global Regulatory Team''s strategic position at regulatoryforums/committees upon GRL request. - Serves as a regional/localpoint of contact with Health Authorities for vaccines in theirremit. Supports global Health Authority interaction strategies,attends and may lead Health Authority meetings, and guides the teamthrough preparation phases. - Identifies regulatory risks andproposes mitigation strategies alongside the GRL. - Helps shape theGlobal Regulatory Project Strategy (GRPS) and ensures alignmentwith core product labeling for vaccines. - Monitors and contributesto the evolution of global regulatory frameworks. - Leadssubmission teams or regulatory sub-teams to ensure filings alignwith project timelines for product launches. - May oversee IND/CTAsubmission strategies to meet clinical trial initiation timelines.- Reviews and contributes to regulated documents (e.g., IB, PBRER,DSUR, RMP). - Supports operational and compliance activities forregulatory deliverables, including submission planning and trackingwithin electronic document management systems. - Acts as a DigitalSubject Matter Expert in working groups focused on digitalinnovation. About You Knowledge, Skills & Competencies -Proactively contributes with curiosity and openness to diverseperspectives. - Understanding of target product profiles, labeling,and biological product development. Experience with vaccines is aplus. - Demonstrates business acumen, leadership, influence, andnegotiation skills. - Strong oral and written communication skills,with effective presentation abilities. - Familiarity withelectronic document management systems (e.g., Veeva Vault is aplus). - Capable of handling multiple products and deliverablessimultaneously. - Strong cultural awareness and ability to navigatemultinational environments. - Passion for new technologies anddigital trends, with the ability to quickly master relevant digitaltools. Experience & Education - BS/BA degree in a relevantscientific discipline required. Advanced degrees (PharmD, PhD, MD,DVM, or MSc in Biology/Life Sciences) preferred. - Minimum 4 yearsof pharmaceutical/biotechnology industry experience, including atleast 2 years in Regulatory Affairs (regional and/or global). -Proven experience with US, EU, and international regulatoryprocesses (e.g., NMAs, LCM activities, briefing documents).Experience with China and Japan is a plus. - Digital training andunderstanding of digital transformation strategies withinregulatory frameworks. - Project leadership experiencepreferred.