Overseeing multiple regulatory marketing authorization teams led by Deputy Managers
Leading PI license applications and the maintenance thereof
Translate high-level strategies from senior leadership into cross-team action plans and support Regulatory to ensure quality and meet stakeholder expectations
Continuous development of the parallel distribution marketing authorization function
Provide strategic regulatory guidance and ensure alignment across all teams
Participate in the change management of increasing efficiency in licensing activities
Keep up to date with internal and external expectations
Take responsibility for internal procedures and managing improvements
Oversee resource and capacity planning across multiple teams
Focus on employee satisfaction

Proven experience in a similar or relevant role
Experience in structured administrative tasks
Masters degree in pharmaceutics, or life science, or regulatory affairs
3+ years' experience in leader position, preferably in pharma/biotech and/or a pharma service organization
Minimum 3 years of experience in the Pharmaceutical or Healthcare industry, or Life Science background
Preferable pharmacist background
Fluent in English (written and verbal communication skills)

Support for work-life balance, flexible management approach
Abacus is a long-term opportunity, we encourage your professional development with internal job opportunities and trainings
Semi-annual company bonus
Cafeteria with optional elements
Annual salary increase
Employee referral program with high rewards
Private health insurance package provided by Medicare after 6 months of employment
AYCM SportPass membership opportunity

Head of Regulatory Affairs – EMA

Key skills