Senior Regulatory Affairs Consultant Your tasks You are part of our international Regulatory Affairs team and report directly to the business directors As a team leader, you will be supervising Regulatory Affairs Managers and Assistants and ensuring the quality of the project work You coordinate...
Read moreNitrosamine impurities were previously detected in batches of medicines containing the Angiotensin-II-receptor antagonist valstartan, leading to worldwide recalls of batches . Since the initial findings, nitrosamine impurities have been detected in some batches of other medicines including the...
Read moreFrom the 21st to the 24th of September, EUDRAC will be exhibiting at the RAPS Convergence 2019 in Philadelphia, Birthplace of the USA. Our team’s experts cover a vast spectrum of expertise, ranging from Small Molecules to Advanced Therapies, and from successful Dossier submissions to the...
Read moreAssociate Director, Regulatory Affairs Be part of our award-winning team South Oxfordshire, UK Full time or Part time (4 days) Permanent contract, competitive salary plus benefits Not your average RA role Are you looking to diversify your role and be exposed to a variety of therapeutic areas and...
Read moreClinical trials are an important step during drug development, leading towards marketing authorisation and thus, market access. According to §40 German Drug Law / §7 GCP ordinance, clinical trials have to be approved by the responsible competent authority (CA). Recently, both German CAs (the...
Read moreThe SmPC can be viewed as a contract between the marketing authorisation (MA) holder of a medicinal product, who drafts the document, and the regulatory agency, who reviews the document. It contains all the relevant product-specific efficacy and safety information and thus provides the very basis...
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