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
Monitoring and interpreting regulatory and legislative changes
Performing core operational regulatory tasks
Developing and maintaining SOPs, working instructions, and regulatory guidelines
Participating in and occasionally leading ad hoc projects
Providing professional guidance to junior colleagues

5+ 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
Willingness to participate in operational tasks (e.g., proof reading)

Support for work-life balance
Flexible management approach
Abacus is a long-term opportunity
Internal job opportunities and trainings
Quarterly 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

Regulatory Specialist

Key skills