Vaccine Registration Manager

Brabant Wallon  ‐ Onsite
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Keywords

Description

THE COMPANY

The Harvey Nash Group was founded in the UK in 1988, and now has offices throughout Europe, America and Asia. The Harvey Nash Group is known for the thousands of successful assignments completed throughout the world. From more than 39 offices, and with 5000 staff and associates, we offer a unique range of consulting recruitment specialising in IT & Engineering recruitment, benefits subcontracting and outsourcing services to our clients. Our departments of and support our customers around the world by placing the senior managers essential to business growth and effective management. For our client we're actively looking for a Vaccine Registration Manager

FUNCTION DESCRIPTION
Vaccine Registration Manager, Regulatory Affairs
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 datapackages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs, Risk Management 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 of regulatory life cycle activities on products from the DTP 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 Clinical RA/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 to ensure 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
Ideally, 4-5 years experience in the pharmaceutical industry which 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

Start date
ASAP
Duration
6 months +
(extension possible)
From
Harvey Nash IT Recruitment Belgium
Published at
12.03.2012
Project ID:
330767
Contract type
Freelance
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