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Regulatory Affairs CMC Specialist Hoofddorp Netherlands,  

Progress PME (company)


Posted on : 18 July 2017

Project Description

Job description: 
  • As an experienced Regulatory Affairs CMC Specialist, our company can deploy you in several areas. In the role of RA consultant, you provide expertise, advice and, where necessary, hands-on support to the customer. 
  • Your expertise is based on vast experience as a CMC RA in the pharmaceutical, biotechnology or medical devices industry. 
  • Depending on your experience and the customer s wishes, you can be deployed as RA (CMC) manager, as member of the CMC team on an RA project team or as RA programme manager. 
  • As manager and/or programme manager, you are responsible for setting up the submission strategy within (the) CMC project(s) and you act as the team s RA expert both internally and externally. 
  • Within the RA team, you coordinate the compilation of CMC documentation for, among other things, clinical and pre-clinical studies (IND, for instance) and/or registration modules (NDA, for instance, post-approval submission). 
  • As a team member, and in cases that arise as a manager as well, you review the documentation for content, quality and consistency and you also write up parts of a module yourself where necessary.
  •  In both roles you work closely with the other disciplines as part of the CMC team, such as Research, Development, QA, manufacturing, QC and marketing.


Our job requirements
  • at least a completed degree programme at Higher Professional Education (HBO) or University level in biotechnology, chemical technology, biochemistry, pharmacy, or similar;
  • 5-10 years of relevant work experience in pharmacy, biotechnology or medical devices, preferably in product development;
  • at least 2-3 years of pre-clinical/clinical and/or CMC-specific RA knowledge and experience;
  • knowledge of and experience with registration procedures for new or modified products within the EU and the US;
  • knowledge of and experience with one or more of the areas below is an advantage: 
    • registration procedures for new or modified products in Japan, China and/or other countries; 
    • experience with meetings and negotiations with registration authorities such as the FDA and EMA;
    • familiarity with the cGMP requirements and/or other relevant regulations and guidelines;
    • knowledge of and experience with project management tools, such as Prince2;
    • strong analytical skills with good knowledge of statistics and process 
    • control systems;
  • good communicative skills, both oral and written;
  • good command of Dutch and English;
  • critical with an eye for detail


Your profile:
  • pro-active attitude;
  • independent, but also a good team player;
  • used to balancing business and/or operational targets and delivering quality work;
  • used to working in a changing organisation;
  • able to advise, convincing, motivating and vigorous;
  • used to communicating at both management and executive level and within the various disciplines involved in the CMC procedure;
  • used to rolling up your sleeves.
     

What we offer        
  • a varied position at a dynamic company;
  • plenty of scope and opportunities to develop yourself, both with regard to the job and soft skills;
  • a very good working atmosphere;
  • possibility to work flexibly or part-time for a good work-life balance;
  • excellent remuneration package, including a lease car and the opportunity to attend training and education courses and congresses.

Locations

2131 HG Hoofddorp Netherlands

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