Regulatory Affairs H/FAstek • BE
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Regulatory Affairs H / F
Astek • BE
Il y a plus de 30 jours
Description de posteSupport 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 of our client's portfolio. 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. Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..). Experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality. CMC experience is a real asset. 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).
Your mission (should you decide to accept it) :
Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.
Your daily activities will be :
- Guide our client by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures.
- Be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager.
- 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 at our client's site.
- It is your hard work and dedication that will make our client ready to achieve new milestones and help patients across the globe.
Scope of work :
You :
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Regulatory • BE
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