Regulatory Affairs CMC Associate Manager
Posted on Apr 24, 2021 by RM IT Professional Resources AG
Regulatory Affairs CMC Associate Manager vacancy for our Basel based client in the pharmaceutical sector.
- Work experience in drug or biopharmaceuticals as well as working knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
- Expertise in regulations, guidelines for NCEs and product life cycle maintenance is desirable
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Outstanding communication and negotiation skills in combination with organizational skills with the ability to execute project objectives through to completion and motivate others to complete deliverables and meet project expectations
- University degree in a relevant profession such as Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalent
- Languages: English, fluent in written and spoken
- Recording high-quality CMC documentation for HA submission, with support and guidance as well as applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Analysing and fixing the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines in combination with identifying content, quality or timeliness issues with source documents
- Being able to keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
- Contributing to the regulatory strategy and identifying the critical issues and lessons learned while participating as a member of the global team
- Establishing and maintaining sound working relationships with partners and customers
Location: Basel, Switzerland
Does 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.
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- All administrative questions
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