At Modis, we are looking for two Regulatory Affairs profiles to work in Wavre: the first with CMC experience; the second with a first RA experience.
Start : January 2020.
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): o 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.
- 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 (CMC) RA experience.
Modis permanent contract
Company car, meal vouchers, insurances and extra benefits
More info? 028011665
Ready to apply? Send your CV to firstname.lastname@example.org