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Regulatory Affairs Associate

Romania - Any Region - Home Based Date posted 05/12/2022 Job ID 82142BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

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

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