Regulatory Affairs Professional

1 week ago

King of Prussia PA, United States Parexel International Corporation Full time

We are recruiting for experienced Regulatory Affairs Professionals on various levels. 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.

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 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

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

RequiredPreferredJob Industries
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