Senior Manager - EU ( Regulatory Affairs)

Role Summary
Lead end-to-end EU Regulatory Affairs activities with full ownership of pre-submission strategy, right-first-time high-quality dossiers, and lifecycle management across EU/UK markets. The role will drive efficient execution of all submission procedures (DCP, MRP, RUP, National), ensure proactive deficiency management, and lead cross-functional alignment to enable timely approvals and product launches.
The position also requires team leadership, regulatory oversight, and stakeholder engagement with agencies and partners.
Key Responsibilities
Regulatory Strategy & Pre-Submission Excellence
• Define and execute regulatory strategies for EU/UK submissions, ensuring alignment with business and market timelines
• Drive right-first-time, high-quality dossier development (Modules 1–5) with strong focus on completeness and compliance
• Lead pre-submission readiness, including gap assessments, risk identification, and mitigation plans
EU Submissions
• Manage end-to-end submissions for:
o DCP, MRP, RUP and National procedures
• Ensure compliance with EMA, MHRA, ICH, and regional regulatory requirements
Deficiency & Query Management
• Lead efficient handling of validation queries and deficiency letters
• Drive cross-functional coordination (CMC, QA, QC, R&D, partners) for timely and quality responses
• Ensure risk-based, scientifically robust justifications aligned with agency expectations
Documentation & Compliance
• Author/review Module 1–5 content, including:
o SmPC, PIL, labeling (QRD compliant)
• Ensure eCTD readiness, publishing accuracy, and submission compliance
• Maintain adherence to global regulatory standards and cGMP requirements
Stakeholder & Agency Management
• Serve as primary interface with EU regulatory authorities and partners
• Support customer interactions, due diligence, and licensing activities
• Drive alignment with internal and external stakeholders for submission success
Leadership & Team Management
• Lead and mentor a team of regulatory professionals
• Establish clear deliverables, timelines, and accountability
• Build capability in EU regulatory strategy, dossier quality, and execution excellence
Required Skills & Expertise
• Strong hands-on experience in EU regulatory procedures (DCP, MRP, National, RUP)
• Proven expertise in eCTD dossier preparation, review, and submissions
• Demonstrated experience in deficiency management and agency interactions
• Strong understanding of EMA, MHRA, ICH guidelines and expectations
• Excellent technical writing, review, and regulatory risk assessment skills
Qualifications
• M.Pharm / B.Pharm (or equivalent)
• 12+ years of Regulatory Affairs experience, with strong EU exposure
Key Competencies
• Strategic thinking with execution excellence
• Strong ownership and accountability mindset
• Effective cross-functional collaboration and stakeholder management
• Ability to manage multiple complex submissions under tight timelines
• Proven team leadership and capability building
Success Indicators
• High rate of right-first-time dossier acceptance
• Timely approvals with minimal deficiencies
• Strong regulatory compliance and inspection readiness
• Effective team performance and delivery consistency

Work arrangement
No