Manager Reg Consulting (CP/DCP/MRP - Submissions- EU market)

Job Responsibilities

• Portfolio Management - Lead regulatory strategy independently across a portfolio of global products.
• Manages end-to-end regulatory lifecycle: MAAs, renewals, variations, HAQs, annual reports, xEVMPD, GMP clearances, safety updates/PSUR/PSUSA/RMP
• Strong expertise in EU markets for procedural (CP/DCP/MRP/National) submissions, Worksharing, Supergrouping and global regulatory requirements.
• Acts as primary liaison with clients, regulatory authorities, and cross-functional teams.
• Leads and reports on client/regulatory agency meetings, providing strategic and operational regulatory guidance to client and internal team.
• Oversees project teams, mentor junior staff, and monitor utilization/performance.
• Drives quality improvement and process efficiency initiatives for client projects.
• Provides technical solutions to complex regulatory challenges and act as subject matter expert (SME)
• Proficient in Regulatory Information Management Systems (RIMS), Veeva Vault, and electronic document management platforms.
• Ensures accurate document management, version control, and tracking systems to maintain compliance and audit readiness.
• Delivers internal training and knowledge sharing across RA and other departments.
• Supports business development through proposals, builds regulatory systems and infrastructure to support GRAS initiatives.
• Represents the company at seminars, conferences, industry associations, authors articles for trade journals etc.
• Excellent written/verbal communication skills
• Flexible in managing multiple global projects, adapting to evolving regulations, and driving successful outcomes
• Ability to lead diverse teams, build strong client/regulator relationships, and influence cross functional stakeholders.