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Snr Regulatory Affairs Associate (Netherlands OR Belgium)(12month FTE)

Amsterdam, North Holland, Netherlands Date posted 08/01/2019 Job ID 51977BR

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.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

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
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – 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

You will act as a Regulatory Project Lead on assigned clinical research projects. 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). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Scope of responsibilities:
• To prepare and coordinate of regulatory deliverables for assigned projects in the Netherlands and other countries, including close cooperation with regulatory authorities
• To act as local regulatory contact and regulatory lead for assigned studies
• Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.
• Working under the general direction of the CTRS Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time
• 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 and national requirements
• May prepare and/ or deliver presentation with the support of senior colleagues
• Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope

Qualifications

• Education:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.

• Minimum Work Experience:
Several years’ experience in an industry-related environment (CRO or pharma companies)

• Language Skills:
Dutch native speaker, at least fluent vocal and written English, French language would be a plus.

Key Competencies:-
• Results Orientation
• Interpersonal Communication
• Teamwork & Collaboration
• Solving Business Problems

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