Tel: 01753 868 960
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  • Salary Upon application
  • Business Type Global Pharmaceuticals
  • Job Type Full-time
  • Location near Basel, Switzerland
  • Background Our client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for an experienced Regulatory Submissions Specialist to work in Drug Regulatory Affairs at their Swiss HQ on the borders of France & Germany.
  • Primary Duties Collaborate with project leaders, submission teams and the editorial group to plan/coordinate/compile/track/manage/QC eCTD submissions of EU procedures and provide eCTD expertise to ensure effective execution of submissions. Be aware of the changing eCTD regulatory environment and implement new guidance accordingly. Assist with software validation, testing of new releases/applications and system implementation. Provide training on eCTD publishing processes & technology requirements, and ensure eCTD compliance.
  • Qualifications A fundamental understanding of eCTD regulatory guidance in the EU and 2y+ experience of electronic publishing of documents, specifically electronic submissions in eCTD format. Excellent IT skills (Acrobat), a customer-orientated attitude and fluency in English are vital.
  • Job Number 18/017
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  • Salary Very attractive hourly rate
  • Business Type Global Pharmaceuticals
  • Job Type Contract x1year (full-time)
  • Location near Basel, Switzerland
  • Background Our client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for an experienced International Project Manager to work at their Swiss HQ on the borders of France & Germany at a senior level in Drug Regulatory Affairs and liaise with affiliates
  • Primary Duties Responsible for providing international regulatory strategy, maintaining knowledge of international regulatory legislation/guidelines, liasing & coordinating submissions & affiliate/partner activities for NCE dossiers and life cycle of marketed products, responding to questions from Health Authorities, coordinating registration samples, archiving submitted dossiers & relevant HA communications, evaluate relevant sections of contracts & quotes.
  • Qualifications Life science graduate with sufficient regulatory affairs experience to have a good grasp of international regulatory legislation/guidelines. Able to work in a multicultural environment, display excellent communication & interpersonal skills and work independently as well as in teams. Fluency in English is an absolute requirement.
  • Job Number 18/018
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  • Salary Attractive hourly rate (50-65CHFph)
  • Business Type a leading biopharmaceutical company
  • Job Type One year contract (minimum)
  • Location Basel area of Switzerland
  • Background Our client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for an experienced Regulatory Affairs, Labelling Manager at their Swiss HQ on the borders of France & Germany.
  • Primary Duties Process improvement (review & adapt to changing requirements) to ensure compliance with internal policies on labelling. Manage the translation of EU Annexes (within the framework of labelling variations/original MAA), coordinate translations of CTA relevant documents, and maintain a database of translators and world-wide approved labels. Ensure harmonised worldwide safety labelling (CSDS) for consistency & compliance with CPSI.
  • Qualifications Demonstrable experience of labeling experience (3-4y) in a major pharmaceutical company, including liaison with worldwide colleagues to ensure timely implementation of global safety labeling changes of CSDS in local product information. Fluency in English is an absolute requirement, as well as good working knowledge of German to communicate effectively with others.
  • Job Number 18/016
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Blue Heron Ltd.

Contact Lynne Dowse or Peter King Tel 01753 868 960 Fax 01753 859 172 Email This email address is being protected from spambots. You need JavaScript enabled to view it. This email address is being protected from spambots. You need JavaScript enabled to view it. Address Blue Heron Ltd, Heronwood, St Leonard's Hill, Windsor, Berkshire SL4 4AT