Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), UK (London), Germany (München), and in the US, (Boston).
We are in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.
Due to our dynamic growth, we are looking for a Regulatory, Quality and Pharmacovigilance Coordinator Benelux - Mechelen (BE) or Leiden (NL) based -
Act as the local contact for Regulatory & Quality compliance, Pharmacovigilance, and Medical Information activities, with both our internal (local and global) and external (National Competent Authorities and consultants) stakeholders, ensuring full compliance with all applicable laws, regulations, and national Codes of Conduct in the Benelux. This role reports to the Benelux Medical Director Benelux.
More in detail you will:
- Act as local single point of contact (SPOC) for global functions in Regulatory Affairs, Medical Information, Compliance, Pharmacovigilance and Quality Assurance.
- Monitor all applicable laws, regulations, and national Codes of Conduct to ensure full compliance of GxP-related activities in the Benelux.
- Act as primary contact for regulatory authorities and for external consultant in the Benelux, ensuring compliance of Product Information, approval of artworks for packaging materials, implementation of aRMA, and keeping oversight of local clinical studies and medical need programs.
- Coordinate all local GxP-related SOP trainings related to Regulatory Affairs, Medical Information, Compliance, Pharmacovigilance and Quality Assurance.
- Act as the GDP-Responsible Person; ensure the implementation and maintenance of the local QMS including SOPs for product Recall, Complaints, Returns, Customer and Vendor validation, etc.; achieve inspection readiness through self-inspections; lead the local Quality Assurance Steering Committee; establish and maintain Business Continuity Plan.
- Represent the company as the local contact person for Pharmacovigilance (LCPPV) and operate in close collaboration with the EU QPPV; keep oversight of all PV related activities (AE reporting, aRMM implementation, Patient Support Programs (PSP), Market Research Programs (MRP), vendor oversight, local literature review, etc.).
- Support the regulatory/compliance/scientific review of local promotional and non-promotional materials/activities according to all applicable laws, regulations, and National Codes of Conduct in the Benelux. Act as back-up for the RIP (Responsible Person for Information and Publicity) in Belgium.
- Support Finance & Global Compliance with the reporting of transfers of value (ToV) into the national transparency registers (Sunshine Act).
- Keep oversight of local Medical Information activities and processes and serve as primary local contact with global Medical Information (Medical Information enquiries will be handled by global, external vendors or Medical Affairs).
- Ensure a smooth transition of all local Benelux activities and responsibilities following the MAH transfer of a centrally authorized product.
- Work with commercial and market access to realize cross-functional objectives.
- You are pharmacist or master in pharmaceutical sciences, doctor or master in medicine, veterinarian or master in veterinary medicine, chemist or master in chemistry, biologist or master in biology, bio-medic or master in the biomedical sciences with +5 years of pharmaceutical/biotech industry experience at a local operating company at Benelux level.
- Expert knowledge of local pharmaceutical legislation and codes of conduct, and efficient communication to relevant local and global functions, including national competent authorities in the Benelux.
- Able to fulfil the task of GDP-Responsible Person.
- Experience as coordinator of trainings for all in-country employees on Compliance, PV, Med Info, Quality & Regulatory procedures with support from relevant global functions.
- Good knowledge of PV related activities (AE reporting, aRMM, PSP, MRP, vendor oversight); experience as local contact person for pharmacovigilance (LCPPV) is preferred.
- Experience with Regulatory review of (non-)promotional materials and events; qualification as a Responsible Person for Information and Publicity (RIP) is an asset.
- Committed to combine business acumen with highest ethical standards, ensuring compliance with all applicable laws and company policies.
- Excellent organisation and coordination skills when dealing with complex projects; demonstrated solid problem-solving skills; result oriented.
- Ability to think strategically and tactically from a Benelux perspective.
- Ability to influence, negotiate, and effectively collaborate with other functions, including global regulatory affairs, medical affairs, commercial, quality and supply, pharmacovigilance.
- High degree of flexibility, resilience, and assertiveness are essential for success.
- Excellent written and verbal communication skills in English and Dutch, French and German are a plus.
- Ability to drive initiatives without direct line management authority, to meet deadlines and set priorities.
What is in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!