Polpharma

Compliance

• 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

Regulatory Affairs Specialist