, pharmacovigilance, global quality management and data and document management, we are looking for an expert in Regulatory Affairs. ROLE DESCRIPTION Senior Specialist Regulatory Affairs RESPONSIBILITIES - provide primary contact
sciences - 1+ years of experience with Regulatory Affairs - Good organisation skills and an eye for detail - Knowledge and or experience with the Belgian Authorities is preferred - Fluent in Dutch and English (French is also preferred) Are you interested and do want to apply for this
responsible for drafting and maintaining the technical documentation for ophthalmic medical devices. You will ensure that this information is delivered to the regulatory body on time to obtain CE marking. RESPONSIBILITIES - Obtaining CE marking for medical ophthalmic products ...
means you will be responsible for the entire registration of several products getting acquainted with all facets from a to z in regulatory affairs. RESPONSIBILITIES - Doing own research and making sure the dossier is finished successfully; - Working on generic substances
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced ...
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
applications) while collaborating with other functions involved - Collaborate with Global Regulatory Affairs - To update and be up-to-date on regulatory legislations, including local regulations and communicate this effectively REQUIREMENTS - Minimum bachelor degree in life
CEP applications) while collaborating with other functions involved - Collaborate with Global Regulatory Affairs - To update and be up-to-date on regulatory legislations, including local regulations and communicate this effectively REQUIREMENTS - Minimum bachelor
DESCRIPTION As a junior regulatory affairs contractor you will support the regulatory affairs managers and mainly be responsible for labeling activities. Initially it is a temporary position for at least 12 months with a possibility for permanent employment. RESPONSIBILITIES
regulatory affairs contractor you will support the regulatory affairs managers and mainly be responsible for labeling activities. Initially it is a temporary position for at least 12 months with a possibility for permanent employment. RESPONSIBILITIES - Control labeling
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 ...
for the engagement with the external regulatory environment, within a defined area. RESPONSIBILITIES - Prepare and manage regulatory documents - Ensure compliance a long with the companies expectations - Build relationships with key stakeholders - Maintenance of
focussing on regulatory aspects - Prepare regulatory applications - Close communication with internal and external partners (EMA, FDA) - Ensure that you are up-to-date concerning changes in regulatory legislation and communicate findings to other staff members REQUIREMENTS
Review promotion and non-promotion materials - Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy - Disseminate relevant information to team(s) as appropriate - Participate in local regulatory process improvements initiatives
Analyze data scientifically and statistically Write technical customer reports as well as CMC regulatory documentation Solve problems and issues by offering practical solutions that are compliant with regulatory requirements Follow-up on dossiers after submission Remain up-to-date on all new laws and