Prepare, review, and submit regulatory dossiers (eCTD) for Marketing Authorisations, variations, and renewals in the EU and worldwide
Assist in developing and implementing regulatory strategies for new and existing products
Coordinate and prepare responses to queries from regulatory authorities
Collaborate with cross-functional teams and external partners
Support lifecycle management activities and maintain regulatory data
Work in a multinational and multilingual environment, collaborating with global teams, partners, and B2B clients across different geographies and cultures

University degree in Pharmacy, Chemistry, Biochemistry, Medicine, Biotechnology, or a related field
Minimum 3 years of experience in Regulatory Affairs or drug registration
Familiarity with EU guidelines for registration processes and post-registration changes
Knowledge of regulatory requirements in countries outside the EU is an advantage
Advanced level of English (both written and spoken), enabling fluent communication and documentation work
Computer literacy, including MS Office skills
Strong communication and collaboration skills
Good organizational skills and openness to change
High level of responsibility, precision, and attention to detail
Ability to work effectively in a team environment

Regulatory Affairs Specialist

Key skills