Unterstützung im Bereich Regulatory Compliance - Übernahme der Kommunikation mit den unterschiedlichen Abteilungen innerhalb des Unternehmen und externen Partnern - weitere Aufgaben bei Bedarf REQUIREMENTS - erfolgreich abgeschlossenes Studium, z.B. in der Pharmazie, Chemie oder
to come to good agreements with regulatory authorities - A minimum of five years experience working in a pharmaceutical/biotech environment - Good problem solving skills - Experience with managing people Are you interested and do want to apply for this role, please fill out your
close knit to these regulations. You will be the contactperson for external stakeholders as for instance Notified Bodies, or Nefemed. You will be of support to professionals in the company regarding compliancy questions and regulatory challenges. RESPONSIBILITIES ...
to deliver compliant complex medical devices. The Regulatory Affairs Manager will be participating in the early phase stage of the development of new medical devices. You will ensure quality and regulatory aspects from early phase design, to design to manufacturing. You will make sure that the Design History
product improvement/development. Quality and development go hand in hand here and result into customer satisfaction. ROLE DESCRIPTION To ensure the developments and innovation reach the customer you as European Regulatory Affairs Manager will be in charge
RESPONSIBILITIES - Ensure activities compliant to local regulatory requirements - Registration and maintenance of regulatory dossiers - Regulatory Strategy Development - Regulatory Intelligence Management - Regulatory Risk Assessments - Focus is on European regulatory requirements - Support/Advice
REQUIREMENTS - beschikt over een afgeronde universitaire studie richting zoals industrie apotheker/biofarmaceut of chemicus - minimaal 5 jaar werkervaring op het gebied van Regulatory Affairs - communicatief en schriftelijk vaardig, zowel in het Nederlands en Engels - kent de verschillende
regulations concerning pharmaceuticals REQUIREMENTS You have a Masters degree in a chemical or pharmaceutical discipline (bio-engineer, pharmacist, chemist, ); a PhD degree is advantageous You have experience with writing the CMC module of regulatory dossiers of chemical and/or
Russia, Turkey Middle East REQUIREMENTS - 3-5 year of experience in Medical Devices - Knowledge of regulatory submissions - Knowledge of regulations outside of Europe - Flexible attitude - Good knowledge of both Dutch and English - Able to move for the duration of the
to Agriculture); Min. 5 years of experience in communication projects; Public Affairs / Government Relations experience is required; Experience with Agriculture business is a big asset; Outstanding communication skills; Good overview of registration processes on EU level; Polish and English â ...
a dedicated team of Regulatory Affairs Specialists, being a part of the Corporate Regulatory Affairs organisation. RESPONSIBILITIES - Regulatory support of strategic projects and co-ordination of regulatory activities related to the portfolio evaluated, developed and marketed
manage all aspects of the project work - Maintaining regulatory files and records of contact with regulatory authorities - Maintain up-to-date knowledge of relevant regulations (EU and US) REQUIREMENTS - Bachelor degree (or higher) in a scientific field - A minimum of 5
collaboration between different departments and colleagues at different locations REQUIREMENTS - Academic degree in a life science related field and academic work level - At least 4-6 years of experience in regulatory affairs in a pharmaceutical or healthcare organization ...
In this role you will be the quality manager for the entire plant located Antwerp. You will be the QA representative for both internal affairs (QC and production) and external (regulatory authorities and customers). You will have skills in people management but also a hands-on mentality when needed
as managing artwork and master data revisions according to regulatory expectations. RESPONSIBILITIES The SCM main responsibilities include developing an effective launch strategy based on requirements from regional supply chain, converting strategy into GMP