Regulatory Affairs CMC (Associate) Manager

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Regulatory Affairs CMC (Associate) Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:Working experience in Regulatory Affairs in the pharmaceutical or biopharmaceutical sectorAcademic degree in science areas such as Chemistry, Pharmacy, Biochemistry, Biotechnology and Biology or equivalentExpertise in chemistry, biotechnology, analytics and pharmaceutical technology, exposure to drug development is a strong plusProficiency with regulations, guidelines for NCEs and product life cycle maintenance combined with reasonable approach to risk assessmentProven track record of working with extended, multinational project teams and coordinating activities simultaneously on multiple projects under pressure of timeAbility to critically evaluate data from a broad range of scientific disciplines paired with computer literacyStrong analytical, organizational and problem solving skills with attention to detailLanguages: English, fluent in written and spokenYour tasks:Ensuring high-quality CMC documentation for HA submission in accordance with agreed CMC global regulatory strategiesAssuring technical congruency and regulatory compliance as well as meeting agreed timelines and e-publishing requirements throughout project lifecyclePreparing CMC responses to health authority questions during development, registration and product lifecycleIdentifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelinesDefining content, quality and timeliness issues with source documents that may impact submission quality or timelinesImproving knowledge regarding regulatory guidelines and requirements in all global regions as well as for new technical trendsParticipating as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learnedProviding support to the general department such as DRAGON support, to the annual and product renewal writing, source documentation and other database entry activities

Start:

Duration:

Location:

Ref.Nr.:12/2020

12MM+

Basel, Switzerland

BH16118Does 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.