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Senior Regulatory Affairs Lead - CTA

Vilnius, Lithuania Additional Locations: Vilnius, Lithuania Job ID R0000016313 Category Regulatory / Consulting Date Posted 11/07/2023
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Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Relationship-builder
  • Results-driven
  • Strategic

About This Role

We are currently looking for Senior Regulatory Affairs Lead (Consultant) with experienced in Clinical Trail Applications (CTAs) under EU-CTR directive. This role can be home or office based (Vilnius).

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.

Ideal candidate will possess:

  • University degree in a science discipline

  • Background in clinical trial management

  • 2-5 years of experience in Regulatory Affairs

  • Good level of knowledge of the Clinical Trail Submissions on a local and regional level

  • Working knowledge of submissions under EU CTR direcitve

  • Project Management experience - nice to have

  • Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.

  • Customer-oriented and autonomous

  • Fluency in English is a must along with the local language.

Apply Now

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