Senior Regulatory Affairs Associate - Clinical Trials
Parexel International Corporation
Additional Locations: Prague,,Czechia
We are currently recruiting for an experienced Regulatory Affairs Professional who worked with Clinical Trail Applications (CTA). In this role, you will focus on clinical trial submissions for Czechia, Slovakia, Canada and occasionally other countries. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The role can be based in our office in Prague or anywhere else in Czechia (home based)
Key Deliverables in the role:
Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
Regulatory submission of Clinical Trial in Czech Republic according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
You may be involved in local, regional, and/or global projects
You will need:
Educated to at least Bachelor of Science level or Bachelor of Science
Relevant clinical research experience in regulatory affairs and management of international clinical trials
Extensive prioritization skills; must be able to resolve conflicting priorities to meet tight deadlines while maintaining quality and attention to details
Ability to work with a multinational team, focusing on multiple issues under tight timelines
Creative problem-solving skills, which supports client-focused approach to work
Fluent in written and spoken English
Job posted: 2023-08-30
