Are you an experienced regulatory professional who wants to make an impact for our international clients in the pharmaceutical, cosmetics, and food industries? Then we would love to talk to you!
Due to the expansion of our team in Veenendaal, we are looking for a Senior Regulatory Affairs Specialist responsible for the coordination and compliance of registration dossiers. You report directly to the corporate Head of Regulatory Affairs & CMC in Switzerland and coordinate CMC regulatory activities in Veenendaal.
What you will be doing
- You prepare and maintain registration dossiers (CEP, DMF, ASMF) for our Active Pharmaceutical Substances and new substances/markets.
- You coordinate the submission of registration dossiers within the RAC department to the relevant Health Authorities and monitor compliance.
- You are performing a regulatory review of CMC source documents and advise on any additional development activities required.
- You assess the regulatory impact of changes in production and validation processes, change control, and deviations.
- You maintain contact with Health Authorities and clients and respond to their questions.
- You identify new laws and regulations and translate these into concrete regulatory actions.
- You manage the REACH registration dossiers and support applications for Health certificates (NVWA).
- You support internal improvement (local and global) and client-focused regulatory projects.
