Point of reference for all legal, regulatory, compliance & quality matters.
Managing all activities related to applicable regulatory affairs, such as (co-)developing internal policies and procedures, providing information on national requirements and providing internal compliance training.
Responsible for the Quality Assurance Management system. You initiate updates of, and start-up new procedures and policies and you ensure the administration of all medical agreements, required approvals and transparency obligations.
Ensuring that our company in the Benelux meets all necessary compliance measures (legislative and objective) and that appropriate risk mitigation/control measures are in place.
Overall contactperson for risk assessment, audit review, monitoring & managing compliance within the Benelux.
Provide advice, guidance and support with regards to compliance.
Identify the lack of and/or improvements to policy and process, assess effectiveness of current policies and processes and recommend and implement required changes.
Direct, manage and maintain contact with the external support (pharmacovigilance, regulatory).
Maintaining data privacy regulations and act as DPO (data protection officer).
You work closely with the Responsible Person (external) and Head of Shared Services Operations. You report to the Head of Shared Services Operations.
A bachelor’s or master’s degree.
Minimum of 3 years experience in a quality control, quality assurance or regulatory affairs role (preferably in pharmacy).
Fluent in English and Dutch.
Full-time availability (40 hours), part-time (min. 32 hours) is negotiable.
Excellent verbal and written communication in Dutch and English.
Excellent attention to detail.
For this job you need to be able to travel to the office. So you must live within an acceptable travel distance from the company's office near Breda.
Our customer is an international medical company with a long history. The company has been active and successful in the relevant therapeutic area in the Benelux for several years. The outlook is good and the ambition is clear.
The group has a European head office, but its home base for the Benelux is in the Netherlands. The culture can be summarized as professional and human. An excellent employer, where many people are very loyal and have been in the right place for years. The team is friendly, approachable and direct. It is a very accessible and friendly company. Lines are short and personal input is highly appreciated. Deliver good work to celebrate successes together is important.
A good salary
Annual financial bonus based on company results.
Home working allowance of €2 per day and kilometer allowance of €0.25.
Expense reimbursement in accordance with the company's claims policy.
Relevant company property (such as a laptop and mobile phone).
Pension scheme via ASR (Netherlands) or Axa (Belgium)
Employee insurances (travel, accident, and disability insurance).
32 holidays based on fulltime employment.
Flexible working hours and the possibility to work partly from home.
A large international network of colleagues who are happy to share their knowledge with you.
Joep van Mil
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