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Regulatory Affairs CMC Labelling Consultant - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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  • AdresSwitzerland,
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Regulatory Affairs CMC Labelling Consultant

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  • Regulatory Affairs CMC Labelling Consultant- 3 Months Contract, Home based/Remote, Switzerland Level: Regulatory Affairs CMC Labelling Consultant Contract: minimum 3 Month Contract Location: Home based/Remote (Switzerland) Summary We are looking for a Regulatory Affairs labelling to consultant to manage CMC and labelling activities for EU. The successful candidate should have a strong grasp of labelling requirements for relevant regulatory authority as well as experience with CMC module 3. The details are as follows; Responsibilities * Experience of the CMC in order to manage existing projects and experience with submissions * Preparation of CMC documentation for global submissions and strong experience in technical writing * Making certain that CMC content meets relevant requirements and meets excellent written standards * Experience with compilation of module 3 of the CTD, quality and compliance * Tracking and follow up of regulatory information * Experience with analytical and technical aspects of CMC * Responsible for managing the labelling process, label changes and company records * Provide support for product portfolio in order to meet deadlines for maintenance and compliance * Develop and maintain labelling documents (SmPC, PIL & Label) for EU procedures (NP, MRP, CP) * Ensure labelling quality and compliance with global regulations throughout the drug product label lifecycle. * Responsible for timely completion of labelling documents according to internal SOP standards and external regulatory standards set by the relevant regulatory authorities * Strong understanding of SOP's with comprehensive understanding of the process and systems in place to ensure quality and compliance * Experience with managing interactions with multiple regulatory authorities Education * Degree in relevant qualification e.g. Master in Pharmacy, Chemistry * Minimum 5 years' experience in labelling with an ability to work with scientific documents * Strong experience with review and writing of CMC documentation * Excellent written and verbal communication in English * Strong IT skills e.g. MS office, Adobe acrobat, MS Project, Documentum This is a 3 Months contract with a strong possibility of an extension. Please contact: Amie Touray Hydrogen Group (0) #LI-AT1


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