Head of Regulatory Affairs and Quality Assurance Benelux
Quality and Regulatory Affairs department
Lead and manage a pool of talented people on a daily basis; to improve the overall working of the QA/RA department.
REGULATORY AFFAIRS & QUALITY ASSURANCE
Being a crucial link between the company, its products and the regulatory authorities, you ensure that the company adheres to internal and external regulations. Combining legal, technical, business and regulatory experience, you advise and support the company in their product development, marketing and after sales support;
· Overall responsibility for the Quality Assurance in the group;
· Implement cost effective QA operations to ensure a lean and agile structure;
· Assist in building and maintenance of QA systems with a mission to simplify where possible.
Fulfillment of PV legislation;
Responsible for developing and facilitating the relationship with the medical/scientific community, internal partners and patients, by communicating product-related information;
Responsible for contents of training for internal staff.
· Preferably pharmacy/chemistry graduate;
· Minimum 10 years’ experience in the pharmaceutical industry, (include significant experience in GMP and GDP, in roles of a related discipline e.g. Quality Assurance, Operations) and RA;
· Minimum 5 years’ experience at senior management level;
open-ended contract + interesting extralegal advantages