Regulatory Affairs Associate

Bucharest, Romania
08 Apr 2021
20 Apr 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

Parexel Consulting is currently looking for an Associate to join the Clinical Trial Regulatory Services EU Consulting team based in the Bucharest office. This is an ideal role for someone who would excel working in a fast-paced international team.

• As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOPs).
• You will coordinate and manage flow of information, track project progress, and identify and solve problems in a team-oriented environment.
• You will be involved in critical reviews of key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review.
• You will interface with the project team, the sponsor and the regulatory authorities on regulatory and technical matters, as appropriate.
• You are expected to acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and disciplines areas relevant to assigned projects and advise clients and internal staff accordingly.
• Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Key Accountabilities:

• To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.
• To act as regulatory project leader for assigned international studies.
• Working under the general direction of the Head of Consultants Team/Project Lead, taking responsibility for ensuring that the client work is performed and delivered on time.
• Preparing, reviewing and compiling regulatory Clinical Trial Approval applications, amendments, and end of trial notifications.
• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs.
• Preparation and review of drug labels to ensure compliance with GMP Annex 13.
• Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.Qualifications

Ideal candidate will possess:

• Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO.
• A degree in a science discipline. Advanced degree will be an asset.
• Fluency in English is a must along with the local language.
• Experience in clinical study start-up.
• Ability to work with a multinational team, focusing on multiple issues under tight timelines.
• Good Computer skills.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's PAREXEL. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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