Regulatory Affairs Specialist-Romania

Job description

Description Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials. 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 before submission to CTIS - Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions - Preparation or review of c...