Company An innovative, 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 3 positions available – Manager, Senior Manager and Director level. The client are looking for experienced Regulatory CMC candidates who have worked on development...
Read morePlanning, compiling, and maintaining technical dossiers for submissions across European markets. Keep regulatory compliance aligned with the growth of the company. Ensure the company is up to date with local regulatory guidelines in all market areas and advise key stakeholders accordingly. Support all departments with regulation queries and updates. Coordinate any changes to internal processes ...
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 moreMy client is a global biopharmaceutical leader – focused on creating valuable solutions that make improvements to the lives of people living with neurological and autoimmune conditions now and into the future. As an Associate Director Regulatory Affairs you will have the following responsibilities: Prepare and deliver regulatory operational plans for assigned projects/products within a [&...
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 moreThe position requires the ideal candidate to participate on project development teams. Potentially manage a small team of employees that oversee the product change control process from a regulatory perspective. Participate on project development teams and represent regulatory affairs by supporting project and product teams. Prepare regulatory submissions as required for global approvals for in ...
Read moreCompany An international, clinical stage Biotech About Scienta are proud to be partnered with an innovative biotech with offices in Boston and Munich, who have an impressive portfolio of oncology and respiratory products. Role The Senior/Executive Director Regulatory Affairs will develop and lead the global regulatory affairs strategy across all assets in the pipeline. The […]
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