Regulatory Affairs Specialist

il y a 4 jours

Puurs, Belgique Arcadis Temps plein

As a Regulatory Strategist, you will be part of a team that will interpret federal, state and international regulations as they apply to products, processes, practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Lead Regulatory. You will work in cross-functional teams with different departments (manufacturing, labs, QA, supply,...) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC) in order to support the introduction of new products. Scope of work: Support regulatory submissions (CTD, BLA, NDA,...) of the products by informing site colleagues of regulatory requirements and by authoring the dossier Liaise with regulatory colleagues to communicate and resolve potential issues Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals Experience: Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..) Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA, CMC) and quality Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) Ability to communicate effectively verbally and in writing, good negotiation and influencing skills Dynamic, flexible, enthusiastic and eager to learn Ability to work under minimal supervision and in a team Fluent in written and spoken English

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