We are recruiting for a regulatory Affairs Associate to join our team in Spain! In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus.
We are recruiting for a regulatory Affairs Associate to join our team in Spain! In this role, you will focus on clinical trial submissions. 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 Madrid or remote.
- 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 Spain 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
- 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
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