This is a high-visibility individual contributor role for a senior regulatory professional who can serve as the local regulatory contact point for European authorities, while partnering closely with international headquarters and cross-functional global teams. The position is ideal for someone who enjoys strategic regulatory ownership, hands-on submission management, and operating within an entrepreneurial, internationally expanding environment. Key Responsibilities:

• Develop and execute EU/UK regulatory strategies for pharmaceutical products across development and lifecycle stages
• Act as the primary local contact point for regulatory agencies including EMA, MHRA, and EU competent authorities
• Lead and coordinate regulatory submissions including MAAs, CTAs, variations, renewals, and scientific advice packages
• Ensure maintenance and lifecycle management of existing product registrations across European markets
• Provide regulatory guidance to internal global stakeholders across CMC, clinical, quality, and commercial functions
• Assess regulatory risks and propose mitigation strategies to support timely approvals and compliance
• Collaborate closely with international teams to ensure high-quality dossiers and successful submissions
• Track evolving EU/UK regulatory requirements and evaluate impact on company portfolio and strategy
• Support regulatory communications, agency correspondence, and inspection readiness activities as required

Candidate Profile:

• 10+ years of pharmaceutical Regulatory Affairs experience
• Strong expertise in EU regulatory procedures and submission pathways (MRP/DCP/CP)
• Proven experience with CTD/eCTD submissions and lifecycle management activities
• Hands-on experience interacting with EMA, MHRA, and/or European competent authorities
• Ability to operate independently in a senior individual contributor capacity
• Strong understanding of EU regulatory strategy and post-approval maintenance activities
• Excellent stakeholder management and cross-cultural communication skills
• Experience within generics, specialty pharma, injectables, or oncology is advantageous
• Experience working with Asian/global headquarters or international matrix organizations is highly preferred

 

Why Join:

• Opportunity to play a key role in a growing international pharmaceutical business
• High level of ownership and visibility within European operations
• Exposure to global regulatory strategy and cross-border collaboration
• Dynamic and entrepreneurial working environment with international growth ambitions
• Competitive compensation package and long-term development potential