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Regulatory Affairs Registration Manager Belgium,  

Posted on : 24 June 2017

Project Description

Business LineConsulting ServicesJob DescriptionWe are looking for a medior Regulatory Affairs Registration Manager for one of our clients based in Walloon Brabant. Scope: The regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products licenses by ensuring the planning, dispatch, submission, follow up, approval of data packages due to regulatory authorities (variations, commitments, questions and answers, PSURs/PBRERs, risk management plans (RMPs), renewals, Article 46, updated files, WHO annual reports, new dossier requests,...). Role and main tasks: 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,... Strong involvement in the CTD Module 1 Exhibit a very good understanding and ensure alignment with regulatory legislation.guidelines, particularly relating to administrative procedural aspects Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ensure 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 the Client's Local Operating Companies (LOCs) (in archiving database) Communicate with external regulators on specific enquiries Communicate regulatory updated information to internal stakeholders Participate in (or lead) the development of the SOPs guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow the client's procedures appropriately Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise Be responsible for the Product's Registration activities of one or several projects Identify key issues on registration activities that could prevent achieving objectives and proactively propose solutions. ProfileEducation: University Degree (preferably biological/chemical) Required skills: Hard Skills: Ideally more than 3 years experience in the pharmaceutical industry; this should include at least 1-2 years RA experience knowledge of Regulatory legislation in at least one geographic area Soft Skills: Team spirit, flexibility and accountability ,very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline Integrity Leadership skills Analytical capacity Good organizational skills Flexible work approach; enjoys varied working day Teamwork and collaboration Customer oriented An eye for detail ICT Skills: Microsoft Word PowerPoint Excel Languages: Fluent in English What we offerYou will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues. Who we areKeyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services. Keyrus Belgium Offices: Chée de Louvain 88 - Waterloo-Lasne Rue Emile Francqui, 1 - Mont-Saint-Guibert Nijverheidslaan 3, - Strombeeck Bever CategoryRegulatory AffairsLocationWalloon BrabantContact person Beverley Ebara


Walloon Brabant Belgium

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