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Senior Regulatory Scientist, CMC & Quality - EU United Kingdom, Switzerland, France,  

Voisin Consulting Life Sciences (company)


Posted on : 06 August 2018

Project Description

responsibilities:
  • participate as team Member in a number of the company’s projects, in an international
  •  environment
  • serve as in-house cmc Expert for internal and external projects
  • participate to the definition and implementation of cmc regulatory strategies for development and registration of innovative drugs
  • write, review and assemble high quality regulatory submissions, such as quality modules of Marketing authorization Applications (maa/nda/bla), investigational new drug (ind/impd), variations, preind briefing documents, etc.;
  • provide advice on operational and technical cmc subjects (Manufacturing, analytical development, Validation, specification setting, stability, etc.);
  • provide support for the preparation of agency meetings (eu and us); • monitor, prioritize and supervise projects’ Strategy, timelines, and milestones and communicate them to the project team members
  • ensure Compliance with regulations and applicable guidelines;
  • stay up to date with cmc eu and us trends and requirements.

experience:

personal attributes and skills:
  • excellent command of English (orally and in writing)
  • strong written and verbal Communication, presentation, and facilitation skills;
  • strong Problem Solving skills;
  • demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
  • client- and business-oriented;
  • proven ability to meet deadlines;
  • ability to work across multiple projects and prioritize based on timelines for client deliverables;
  • ability to juggle multiple priorities and adapt quickly to new situations and new project demands;
  • good command of ms office (word, Excel, PowerPoint) is required.

Locations

UKSwitzerlandFrance

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