At Modis, we are looking for an Regulatory Affairs Registration Manager to work in Wavre.
The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide vaccine licences. by ensuring the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc …
The role has the following responsibilities:
- Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
- Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled
- Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
- Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
- Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
- Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
- Ensure the tracking of relevant correspondence with Authorities and GSK Local Operating Companies (LOCs): in archiving database (TRAC-IT)
Communicate with relevant parties:
- Communicate with external regulators on specific enquiries
- Communicate regulatory updated information to internal stakeholders
- Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
- Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
- Be responsible for Vaccine Registration activities of one or several projects
- Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions.
Education, Methodology & Certification Requirements:
- University degree (preferably biological/chemical)
ICT Skills (software, operating systems, hardware, etc.):
- Microsoft Word
Language Proficiency Requirements:
- English: Fluent
- Knowledge of Regulatory legislation in at least one geographic area
- Basic understanding of biologicals/vaccines
- Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
- Analytical capacity
- Good organizational skills
- Flexible work approach; enjoys a varied working day
- Teamwork and collaboration
- Customer oriented
- Can work under stress and to deadlines
- An eye for detail
- Experience in the pharmaceutical industry; this should also include RA experience.
Working as a consultant for Modis means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.