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.
- 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.
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.