Senior Manager Regulatory Affairs

15 hours ago


Greater London, United Kingdom Walker Cole International Full time

Regulatory Senior Manager Walker Cole is searching for a Regulatory Senior Manager for a global pharmaceutical business. This is an opportunity to broaden your scope in Regulatory and join a supportive and growing business. Responsibilities Develop and implement EU regulatory strategies aligned with product and business goals. Evaluate non‑clinical and clinical data, identify gaps, and ensure robust submission dossiers. Prepare, review, and maintain regulatory submissions for specialty and generic products. Support local EU regulatory requirements, product launches, and post‑approval activities. Maintain regulatory document databases and ensure compliance with European guidelines. Mentor and guide junior regulatory staff as needed. Qualifications & Experience Solid experience leading European submissions including DCP, MRP & CP. Strong cross‑functional collaboration, particularly focused on R&D. Leadership of communication between health authorities and scientific advice meetings. Authorship, review and strategic CMC abilities and clinical Phase III experience is highly desirable. Referrals increase your chances of interviewing at Walker Cole International by 2x. Get notified about new Regulatory Affairs Manager jobs in Greater London, England, United Kingdom. #J-18808-Ljbffr



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