Regulatory Affairs Consultant - CTA/EU-CTR (1 year FTC)
Romania, Remote Job ID R0000022237 Category Regulatory / Consulting Date Posted 04/18/2024Overview
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 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
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