Senior Regulatory CMC Manager

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Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:Experience with drug and biopharmaceuticals, chemistry, biotechnology, analytics and pharmaceutical technologyKnowledge of drug development process is advantageousFamiliarity with evaluating data from a wide range of scientific disciplinesSuperb written and spoken communication plus negotiation skills along with a sense of effective planning as well as organizational and interpersonal skillsFinished Degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or a in a similar field, an higher or advanced Degree in either one of these is a plusLanguages: English, fluent in written and spoken,Your tasks:Assisting with the implementation of global CMC submission activities like planning, authoring, reviewing, coordination and submission for assigned projects and productsLeading, Managing and Formulating global CMC regulatory strategies focusing on innovation and maximizing the business benefit in balance with regulatory complianceCreating high quality strategic project documentations and presentations such as project plans, strategic documentation, lessons learned and morePreparing CMC responses to health authority question during the development, registration as well as product stagesWorking on first-class CMC documentation for HA submissions in regards of support and guidance, applying arranged CMC global regulatory strategies, assuring technical congruency and regulatory compliance while meeting agreed timelines and e-publishing requirements during the project lifecycleAnalysing and identifying required documentation for world-wide submissions and negotiating the delivery of approved technical source documents in accordance with project timelinesEstablishing and maintaining good and deep working relationships with partners an customers

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Ref.Nr.:ASAP

12MM+

Basel, Switzerland

BH15986Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.Going the Extra Mile.As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.New to Switzerland? In case of a successful placement, we support you with:All administrative questionsFinding an apartmentHealth- and social insuranceWork permit and much more Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.