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Regulatory Affairs Specialist Senior Freelance

Location: zoetermeer - Zuid-Holland - Netherlands

Job: Pharmaceutical - Temporary

Currently for a leading pharmaceutical client in the Netherlands in Zuid-Holland. 
For this position you will me managing the regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4). 

RESPONSIBILITIES

  • You will be working on the CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy,
  • You will be responsible for the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial. 
  • As the  Regulatory Clinical Trial Application submission manager you will ensure that the required regulatory intelligence is in place to comply with country-specific requirements
  • You will lead a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA life cycle submissions (e.g., Health Authority responses, amendments, etc.
  • You will be responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs. 

PROFILE

  • You have a Bachelor's degree in science required or equivalent experience
  • You have related experience with pharmaceutical or health sciences industry
  • You have at least 4 to 6 years experience within regulatory affairs in the pharmaceutical industry
  • You have an understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required
  • Must have experience working (internship acceptable) in GLP, GCLP, GMP, CCKL (or other lab related quality system, focusing on trace ability) regulated environment 
  • Affinity with automated systems such as LIMS 
  • Experience with pipetting robots such as TECAN is a plus 
  • Fluency in English is a must

PROJECT DURATION

31/12/2018

PROJECT START DATE

May

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

For further information, please contact Loretta Kumi at +31 (0)20 20 44 502 or by email at L.Kumi@panda-int.com.

PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.

Reference: vr5929

INTERESTED?

If you see yourself in this role, please apply by uploading your CV via the apply for this position button. We will review your application and get in touch with you to discuss things further.

For more information, please fill in the form below or call us on +31 (0)20 20 44 502.

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