Regulatory Affairs Specialist-romania

Responsibilities: - Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards - Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions. - Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards befo…