Senior Regulatory Specialist

Role Overview

• Acting as a specialist within the team
• Acquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelines
• Maintaining existing marketing authorizations according to market specific requirements and internal procedures
• Preparing and sending notifications to Trademark Holders in compliance with SOPs and WIs
• Managing end to end submission processes, ensuring high quality documentation and smooth cross functional collaboration
• Monitoring and interpreting regulatory and legislative changes, implementing them in daily operations
• Performing core operational regulatory tasks, including submissions, maintenance activities, compliance support, and documentation management
• Developing and maintaining SOPs, working instructions, and regulatory guidelines, and delivering internal trainings
• Participating in and occasionally leading ad hoc projects, such as proof reading or process improvement initiatives
• Providing professional guidance to junior colleagues and contributing to strategic decision making within the regulatory function.

Requirements

• 10+ years of regulatory expertise in a multinational environment
• Master’s/Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent field
• Strong ability to track, interpret, and apply legislative and regulatory changes
• Professional conduct in English (C1 level)
• Experience in communication with authorities and confidence in handling market specific regulatory expectations
• Ability to work independently, make well founded decisions, and contribute to strategic thinking within the regulatory function
• Capability to manage the full submission lifecycle: from business request to complete documentation, collaborating with graphic designers and business development
• Willingness to participate in operational tasks, including submissions, maintenance, compliance, SOP and WI creation, trainings, and ad hoc projects (e.g., proof reading)

Benefits

• Support for work-life balance
• Flexible management approach
• Long-term opportunity with internal job opportunities and trainings
• Semi-annual company bonus
• Cafeteria with optional elements
• Annual salary increase
• Employee referral program with high rewards
• AYCM SportPass membership opportunity
• Private health insurance package provided by Medicare after 6 months of employment