Vaccine Registration Manager

Brabant Wallon  ‐ Onsite
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Keywords

Description

Vaccine Registration Manager, Regulatory Affairs

For one of our client, we are looking for 2 Vaccine Registration Managers for regio Walloon Brabant.

Tasks and requirements:

  • Involved in the company's regulatory activities related to existing products (both in Europe and outside Europe).
  • Ensure the planning/dispatch/submission/follow up of data packages due to Regulatory Authorities:
  • Variations, Commitments, Questions & Answers, PSURs, RiskManagement Plans (RMPs), Renewals, Scientific Advices, Article 46,Updated files, WHO Annual Reports etc.
KEY RESPONSIBILITIES
  • Organises the preparation, submission and follow-up of MAA and ofregulatory life cycle activities on products on the vaccines portfolio in Europe (centralised, mutual recognition and national registration procedures) and Worldwide.
  • Coordinate, prioritize and plan all the registration activities for the products within area of responsibility. Ensure these plans are updated and communicated appropriately.
  • Coordinate and interact with ClinicalRA/labelling/Safety/Epi/Technical RA for the preparation of the documents part of the regulatory datapackages in order to meet the submission timelines.
  • Ensures that all the aspects of the product safety are closely monitored and fulfil the pharmacovigilance/regulatory
  • Communicate occasionally with external regulators on administrative and procedural enquiries.
  • Exhibit a solid understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
  • Maintain close contacts with the Local Operating Company's toensure shared objectives are achieved.
  • Identify key issues on resource or registration activities that could prevent achieving objectives or that could lead to supply issues and pro-actively propose solutions to management to solve the problem.
PREREQUISITES

Education:
University degree (preferably biological/chemical/pharmacist)

Knowledge:
Some EU regulations (Centralised or mutual recognition or national procedures)/English fluent - oral and written/IT tools

Experience:
Ideally, 4-5 years experience in the pharmaceutical industrywhich include at least 1-3 years RA experience.
Skills: Team spirit, Flexibility and Accountability, Very well organized, Good relationships, Able to work in multi-cultural environment
Where: Walloon Brabant
When: Septembre

The Harvey Nash Group is a recruitment and selection company active in the IT and engineering industry. The Harvey Nash is known for the thousands of successful assignments completed throughout the world as we offer a unique range of consulting recruitment specialising in IT and engineering recruitment.

For more information about this opportunity, please contact Francois Echement.
Start date
ASAP
Duration
Long term
From
Harvey Nash IT Recruitment Belgium
Published at
18.07.2012
Project ID:
394044
Contract type
Freelance
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