Company Regulatory Consultancy About Scienta are proud to be supporting an impressive, full service regulatory consultancy in Munich with a focus on drug development in Europe and the US. Role The role requires at least 15 years of Regulatory CMC experience, or technical CMC development experience in either Small Molecule or Biologic, or cell/gene therapy […]
Read moreManaging multiple client portfolios within medical devices, in-vitro diagnostics and drug-device borderline / combination products. Focussing on regulatory, technical and quality management consulting. Working with clients ranging from start-ups to medium enterprises. Directly managing project delivery within the budgets and timeframes. Assessing project risks and reporting them to the supervis...
Read moreLeading client projects regarding medical device, IVD & MDx products, from design & development through the full life cycle management. Preparing, compiling and maintaining technical files and dossiers, in compliance with regulatory standards. Mapping out and strategizing regulatory pathways in preparation for submission to notified bodies and regulatory authorities. Planning licensing ...
Read moreCompany Regulatory Consultancy About Scienta are proud to be working with a distinguished regulatory consultancy in Breda (Netherlands) with a focus on product development in Europe and the US. Role The role requires at least 10-15 years of drug development experience with 5 years in Regulatory Affairs for Biotech. The role is a mix of […]
Read moreCompany An international BioPharmaceutical company About Scienta are proud to be partnered with an international BioPharmaceutical company who produce innovative medicines for patients with unmet medical needs. Role The client are looking for either an experienced Regulatory CMC candidate who has worked on development projects for Biologics (including authoring of IMPDs and relevant CMC section...
Read moreAbout I am currently representing a leading and highly respected international regulatory consultancy who are looking for either a senior or principal consultant to join their small molecule team. They are looking for candidates experienced in the development side of CMC such as authoring IMPDs and relevant dossier modules. Duties o Authoring of the Quality […]
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