bachelor degree in life science related field - A minimum of 3 years experience in regulatory affairs in a pharmaceutical or biotech industry - Experience and knowledge in pharmaceutical industry, preferably with CMC Regulatory Affairs environment - Excellent communication skills in English and Dutch
Updating of Regulatory requirements - Pre market Regulatory activities - Post market Regulatory activities - Spokesperson for Notified Bodies - Advising Business Manager on RA topics - Formulate and implement RA policy - Responsible for DMF REQUIREMENTS - Bachelor
and medical surgical technology; - Knowledge and understanding of risk-based verification and validation documentation; - Thorough and current knowledge of European, USA and Japanese laws and regulations for medical devices; - Attention to detail with a good insight into key and adjacent areas; - Good
specific file) RESPONSIBILITIES - Update/ Modify the Regulatory DHF history file - Support in the certification of the CE Marking - Revise the clinical studies and evaluations - Writing the clinical/ regulatory file - Support the team in the communications with the notified
in implementing a new product group to the company. Having knowledge on submissions, Technical Files and Dossier making is essential. Both knowledge of CE and approvals outside Europe are essential. RESPONSIBILITIES - Technical Files - Dossier making - Regulatory of
a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse
to Competent Authorities for assigned projects - ensure that regulatory activities are performed at high quality and compliant to local regulatory requirements - provide regulatory expertise to development, registration and maintenance of pharmaceutical products within assigned projects - develop and maintain
For our client, top-tier pharma company we are looking for candidates on the position of Advanced Analytics Manager. Job Description Collaboration in projects of the European Advanced Analytics Team Concept, design, planning and execution of complex statistical analysis (Advanced Analytics, Predictive Analytics), especially in the area of commercial effectiveness and Real World Evidence in collaboration ...
Medical Advisor RESPONSIBILITIES Zu Ihren Aufgaben gehören u.a.: - Medical Information und Medical Writing - Medical Liaison Management - Erarbeitung medizinisch-wissenschaftlicher Informationen - Stellungnahmen zu Produkten und Publikationen - Erstellung
Develops required qualitative and quantitative reports; collates competitor information - Identifies new research opportunities and proactively shares ideas and insights with medical adviser - Ensures conduct of work in line with compliance regulations - Together with other hematology RML’s covers
- Control labeling documents - EMEA - Update the database - Regulatory submissions REQUIREMENTS - 1-2 years of experience with regulatory affairs - University degree in a life science discipline - Eye for detail - Accurate - Fluency in English is a must
documents - EMEA - Update the database - Regulatory submissions REQUIREMENTS - 1-2 years of experience with regulatory affairs - University degree in a life science discipline - Eye for detail - Accurate - Fluency in English is a must Are you interested
- Master degree (or equivalent) in a scientific discipline - Excellent communication and writing skills in English and Dutch - Good negotiation skills - Excellent knowledge of European and American regulatory legislation - Strong leadership skills, strategical reasoning skills and being able
A minimum of 2 years of experience with regulatory affairs - University degree in pharmacy or equivalent - Good communication skill - Good command of Dutch, French and English - Problem solving skills Are you interested and do want to apply for this role, please fill out your application
experience as an assistant/adminidtrator in regulatory affairs - Knowledge of eCTD/NEES - Eye for detail - Good organization skills - Fluent in English Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact ...
- Assist locally in Healthcare Compliance activities where applicable - Coordinating and reviewing briefing documents - Coordinating translation for local Regulatory submission. REQUIREMENTS - Master degree in a life science discipline or a bachelor degree in