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Regulatory Operations Manager (m/w) RIMS - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
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  • AdresGermany,
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Regulatory Operations Manager (m/w) RIMS

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  • Regulatory Submissions Manager (m/w) RIMSOffice-based in Frankfurt, Germany / full-time, unlimitedJob Description:- Participate in the daily activities and workload of site regulatory operations team, ensuring compliance with all SOPs and internal standards- Responsible for project management and implementation of various informations systems such as electronic data management systems (eDMS), regulatory information management systems (RIMS) and submission management systems (SMS) as per the ISO-IDMP.- Contribute to major and complex routine/lifecycle management eCTD submission projects- Maintenance and continuous improvement of publishing tools and standards- Participate in Global Regulatory Operations management meetings- Participate in Global Regulatory Affairs project teams- Provide publishing support to internal cross-functional teams as necessaryRequirements:- Bachelor's Degree in life sciences or information technology preferred- A minimum of 2 years of experience in Regulatory Operations/Regulatory Affairs- Experience with Liquent InSight Publishing suite or alternatively, other Publishing tools, Microsoft Office suite, Adobe, Documentum and eCTD technology- Basic understanding of IT infrastructure- Working knowledge of industry legislation and best practices in Europe- Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, Paper) in Europe- Excellent interpersonal and communication skills as well as organizational follow-up skills- Understanding of the drug development process and knowledge of generics and branded product development is a plus- Skill in working collaboratively in a fast-paced, time-sensitive environment with ability to meet critical deadlines- Fluency in English and GermanTo Apply:i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in Europe and Germany. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology Contract Research Organisations (CROs) and Contract Manufacturing Organisations (CMO's). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, drug safety and Bioinformatics. you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on or email: this role is not suitable, Christian is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


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