Regulatory Affairs Support

BE2012

DPS Group Belgium is looking for an RA Support for an onsite role in Brussels starting 04/01/2021.

Category:
Administrator / Office Commercial
Location:
Belgium
Years of Experience Req.:
>2 years
Date Posted:
15/10/2020
Days Remaining:
3
Employment Type:
Contract
Education Level Req.:
Bsc or Msc degree

DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full-Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are: Pharmaceutical & Biotechnology, Medical Technologies, Oil and Gas, Advanced Technology, Science & Education, Food & Beverage and Energy.

Role

Administrative office routines:

  • Assists in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable - to the European Medicines Agency (EMA) related to new applications, variations, renewals, PSURs etc.

Compliance:

  • Builds and maintains standard Regulatory Official Files as well as Marketing Authoriz550096.519861ation filing and approval binders according to local SOPs.
  • Ensures that regulatory databases and systems are kept updated and complete.
  • Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
  • Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
  • Manages the planning and submission activities for PSURs, in cooperation with regional and global teams.

Editing and labeling:

  • In connection with submission of MA applications, variations, renewals and PSURs etc assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
  • Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.

Art-work development:

  • Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
  • Packaging Material is developed in cooperation with the MMD, RAE coordinators, the Product Manager, and (Sr) Manager Regulatory Affairs.
  • The candidate proof reads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.

Profile 

  • The candidate must have a post-secondary education in scientific science or equivalent.
  • The candidate must demonstrate basic medical and scientific understanding and knowledge.
  • The candidate should demonstrate basic skills and knowledge of local and EU medicines legislation and regulatory procedures.
  • The candidate must have the ability to plan and prioritiz550096.519861e regulatory tasks to meet Merck and local objectives.
  • The candidate must demonstrate good interpersonal and managerial skills, capability of problem resolution and the ability to work in a team environment. Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition.
  • The candidate must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet.
  • For seniority, a minimum of 2 years’ experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.
  • Language: Dutch /French/English + (optional) German reading

Interested and available ?

Send your resume to cvsbelgium@dpsgroupglobal.com or give us a call at 04/85450725. 

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