GRA CMC Scientist (m/f/d)

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Beschreibung



GRA CMC Scientist (m/f/d)

Reference: -en
Start: asap
Duration: 6 MM+

Main tasks:
  • Contribute to the development of global regulatory processes in agreement with the supervisor and interpret existing or new regulatory requirements, evaluate draft guidelines and writes impact assessments
  • Responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements
  • Evaluate available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks
  • Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation
  • Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs)
  • Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials
  • Coordinates and tracks compilation of regulatory documentation required to support new product registrations and relevant lifecycle submissions (e.g. renewals) within the GRAST
  • Present regulatory strategies, risk assessments and mitigation proposals to senior review committees such as GRA Strategy Management Review Team (SMRT) or Global Lifeycycle Review Board (GLRB)


Main qualifications
  • University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous
  • Profound experience in the biotech or pharmaceutical industry
  • Sound knowledge in natural sciences with a focus on biological medicinal products
  • Excellent communication, project management, planning, problem solving and presentation skills
  • Ability to work with minimal supervision based on sound technical and analytical judgment
  • Fluent in English and local language


Main advantages:
  • A very renowned company



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

Referencenumber:
Start
ab sofort
Dauer
6 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
26.06.2019
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1789045
Vertragsart
Freiberuflich
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