Regulatory Affairs CMC Specialist - Netherlands
- 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.
- 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.