Regulatory Affairs Consultant - CTA/EU-CTR (1 year FTC)

We are currently seeking Regulatory Affairs Professionals with experience in Clinical Trial Applications (CTAs) under the EU-CTR directive. Join our team or work on dedicated client projects as a Senior Regulatory Affairs Consultant, Regulatory Affairs Consultant or Regulatory Affairs Senior Associate. We offer Parexel fixed term contract (12 months). The role can be home, or office based in various EU locations. Join our team and be part of a dynamic environment where you can make a significant impact on the success of clinical trials!

As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submissions related aspects of clinical trials. You will serve as the main client contact and be responsible for delivering submission-specific milestones, while offering guidance on submission strategies. Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments. Your role may also involve serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions.

Role Responsibilities:

• Provide leadership and expertise in regulatory and submissions related aspects of clinical trials

• Act as the main client contact and deliver submission-specific milestones

• Offer guidance on submissions expertise to clients

• Participate in EU-CTR consulting and contribute to its operational implementation

• Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials

Skills and Experience required for the role:

• University degree in a scientific discipline

• Background in clinical trial management

• Experience in Regulatory Affairs from CRO/Pharma

• Proven experience with Clinical Trial Submissions on a local and regional level

• Working knowledge of submissions under EU-CTR directive

• Project Management experience

• Solution-oriented and problem-solving skills

• Customer-oriented and able to work in a team as well as autonomously

• Fluency in English is a must (written and spoken), along with proficiency in the local language