(Senior) Regulatory Affairs Officer

brpbWat je gaat doen /bbrAre you an enthusiastic Regulatory Affairs (RA) professional looking to work in an RA department located on the same premises as the production facilities for biological medicines? pbrpDepending on your competencies and experience, you will work as a senior RA officer under the leadership of the manager RA in a team of 4-5 other (senior) RA officers in one or more core activities of the RA department: /pbrullibr/liliPreparation and submission of regulatory dossiers to obtain new product registrations in countries worldwidebr/liliMaintenance of regulatory dossiers of registered vaccines both nationally and abroadbr/liliInitiation of variations in response to change control procedures, changed regulations, or at the request of authorities, and implementation and coordination of resulting actionsbr/liliCritical review of source documents from other departments such as Quality Control (QC), Manufacturing Science Technology (MST) or Production, such as validation, comparability, and stability reports, to ensure these documents are suitable for submission to regulatory authoritiesbr/liliParticipation in projects that have an impact on the regulatory dossier, e.g. new presentationsor major changes in the manufacturing processbr/liliMaintenance of contact with the external company that performs the pharmacovigilance tasks on behalf ofBBiobr/liliMaintenance and setting-up of various regulatory IT systems such as XEVMPD, IDMP, PMS, and the creation of eCTD sequencesbr/liliMaintenance of internal and external relationships with consultants, agents, and national and overarching regulatory authorities such as the EMA, MEB, and WHObr/liliIdentification and interpretation of changed and/or new laws and regulations for marketing authorizationsworldwidebr/liliProvision of(un)solicited advice and responses toquestions about the regulatory dossier from other departmentsbr/liliCoordination of the creation or modification of pharmaceutical artwork, contact with artwork printersbr/liliDetermination and set-up ofthe regulatory strategy for current and new regulatory procedures, in collaboration with the manager RAbr/liliRepresentRA in projects with other departments (including MST and MS) at an early stage, assess impact on product registration proceduresin a timely mannerbr/liliCollaborate closely with other departments/colleagues such as MST, Marketing and Sales (MS), Quality Control (QC), Quality Assurance (QA) and Qualified Persons (QPs)br/liliPerforming final editing on all regulatory dossier documentsbr/liliWriting of RA department proceduresbr/li /ulbrFunctie eisenbrpbWat neem je mee /bbrTo be successful in this role, you should have: /pbrullibr/liliUniversity working and thinking level, i.e. an MSc. degree in a biomedical discipline or BSc. degree in a biomedical discipline supplemented with significant RA work experiencebr/liliKnowledge of international regulatory guidance and marketing authorization procedures for biological medicines, including regulatory dossier granularity and eCTD basic knowledge (ICH M2)br/liliExcellent command of the English language, both spoken and writtenbr/liliMinimum of 3-5 years’ relevant RA work experience, gained within an international environmentbr/liliAffinity with electronic regulatory databasesbr/liliStrong awareness of regulatory compliance and GMPbr/liliKnowledge of pharmacovigilance is highly desirable.br/liliA contract for 32 to 40 hours per week.
When a change in production has impact , the RA department determines the regulatory strategy in consultation with other departments and submits variation applications to the regulatory authorities. The uniqueness of the RA department of BBio is that it is located on the same premises as the GMP production and testing facilities;in other words,there are many direct F2F contacts between the RA colleagues and the colleagues in the production facilities; as an RA professional, you are literally very close to the action, which is quite unique in the Netherlands. /pbrpIn addition to all activities directly related to vaccine production, the RA department is also responsible for managing artwork, packaging, and product information, ensuring compliance with pharmacovigilance legislation in collaboration with an external pharmacovigilance service provider, and maintaining contact with clients and regulatory authorities worldwide. /In addition to existing products, BBio also wishes to register two new products in the EU, making expansion of the RA team a high priority. /pbrHet bedrijfbrpBilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf.