Beschreibung
Junior GPRM/RegCMC Manager vacancy for a globally operating Basel based company in the pharma sector.Your experience/skills:
- Professional experience in a regulatory environment, as well as in drug and biopharmaceuticals
- Working knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
- Know-how of drug development process, regulations, guidelines for NCEs and product life cycle maintenance is a plus
- Ability to critically evaluate data from a broad range of scientific disciplines, work successfully with extended, multinational project teams and coordinate the projects accordingly
- Graduate Degree in Science like Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or any other equivalent discipline
- Languages: English, fluent in written and spoken, good local language skills are an asset
Your tasks:
- Creating high-quality CMC documentation for HA submission with help and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Meeting timelines and e-publishing requirements through the whole project lifecycle as well as preparing CMC responses to health authority questions for the duration of the development, registration and product lifecycle
- Identifying necessary documentation for worldwide submissions and negotiate the delivery of approve technical source documents in alignment with project timelines
- Detecting content, quality or timeliness problems and issues with source documents or any other possible authoring issues that influence the submission quality or timelines
- Keeping wisdom and knowledge up to date regarding regulatory guidelines and requirements all over the world as well as for new technical trends
- Being a member of the global team and actively participating and contributing to the regulatory strategy, identifying the critical problems and lessons learned
Start: ASAP
Duration: 09MM+
Location: Basel, Switzerland
Ref.Nr.: BH16649
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.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health- and social insurance
- Work permit and much more
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