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Regulatory Affairs Publisher

Netherlands   •  €25 - €35 per hour  •  Contract/Temporary, Full time

Regulatory Affairs Associate
Hours: 40 hours
Location: Maastricht or Heerlen Office - Hybrid 2 or 3 days in the office.
Duration: 12 months
Responsibilities may include the following and other duties may be assigned.

  • Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
  • Submissions are produced with electronic publishing tools in compliance with document management standards.
  • Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing, and implementing plans, and providing input to systems designs.
  • Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
  • Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.

Required Knowledge and Experience:

  • Bachelor?s Degree in a life science, clinical research studies or engineering.
  • Initial years of experience in an industry-related environment.
  • Entry level position (0-3 years? experience) and willing to get things done.
  • Preference Regulatory knowledge, (ie Regulatory submissions, Regulatory affairs, global regulatory) and ICH Guidance.
  • Regulatory experience within a medical device or pharmaceutical environment is desirable.


  • Autonomy and proactivity organized knowing how to prioritize and plan.
  • Interpersonal communication.
  • Client focus, results orientated,
  • Flexibility to work in different scenario.

For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: RU-165
  • Posted: 29th August 2023
  • Expires: 26th September 2023

Achieva Group Limited

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