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Regulatory Affairs CMC Specialist Hoofddorp Netherlands,
Progress PME (company)
Posted on : 18 July 2017
- 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
- 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.
2131 HG Hoofddorp Netherlands
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