Company : Baxter Location : Braine-l'Alleud Wallonia From : Talent BE
Each of us are driven to help improve patients’ lives worldwide.
Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.Your Role at BaxterThis is where your motivation addresses challengesYour Team at BaxterThe Specialist (f/m/d) RA belongs to the Benelux CQA and RA department, reports to the CQA/RA Manager Benelux and is responsible to ensure that the product registration lifecycle and related processes are ensured in Belgium, Luxembourg, and the NetherlandsThe Regulatory function values both working together as a team and independently.
We draw energy from working in collaboration with internal and external stakeholders.
As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working.What you will be doing:
RA RoleFor Renal and Acute Therapy products:
Ensure timely preparation, submission and appropriate follow-up of variations and renewal applications.
Act as contact person with local authorities.Respond to questions from regulatory authorities in agreement with the Global Regulatory Lead.Ensure high quality labeling translation and artwork managementReview promotional materials for compliance with local regulationsMaintain good relationships with internal (Global Regulatory Leads, Pharmacovigilance, Business partners, Market Planners, …) and external regulatory contacts (local regulatory authorities)Monitor applicable EU and local regulations, perform impact analysis where needed and keep internal partners appropriately informed.Provide regulatory guidance to business, tenders and project teamsQA SupportSupport Corporate Quality Systems implementation including local requirements to CQA and distributionCoordinate Field Actions implementationHandle non conformities, CAPA and change controlsProvide support in case of inspectionsWhat you will bring:
Bachelor’s degree or country equivalent in a relevant scientific fieldPreferable prior work experience in regulatory or equivalent experience within a pharmaceutical/medical device company, CRO or similar organizationNative fluency in Dutch or French, with proficiency in English and in the second national language (Written and spoken)Office basic knowledge requiredGood interpersonal and communication skills:
ability to collaborate closely with different functions involved and with multicultural teamsOrganizational and project management skills, self-motivation and commitmentsCertified RIP from Belgian FAMHP is a plusIT functional knowledge in Veeva Vault RIM & PromoMat, TrackWise is an assetProficiency in German is appreciated Baxter Braine-l'AlleudWallonia
