Regulatory/Quality & Pharmacovigilance Lead - Germany
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), the Nordics and in US, Boston.
We’re 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: The ‘make-it-happeners’.
Due to our dynamic growth, we are looking for a Regulatory, Quality and Pharmacovigilance Lead Germany
Scope of the job
Act as the local contact for Regulatory & Quality compliance, Pharmacovigilance 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 Germany.
As Regulatory, Quality and Pharmacovigilance Coordinator Germany, you are supported by external vendors and an internal expert reporting to you. You report into the Medical Director Germany.
- Act as local single point of contact (SPOC) for global functions in Regulatory Affairs, Compliance, Pharmacovigilance and Quality Assurance.
- Monitor all applicable laws, regulations, and national Codes of Conduct to ensure full compliance of GxP-related activities in Germany.
- Act as primary contact for regulatory authorities and for external consultant in Germany, 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, Compliance, Pharmacovigilance and Quality Assurance.
- Act as the GDP-Responsible Person (preferred) or coordinate this function; 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.
- Keep oversight of all PV related activities (AE reporting, aRMM implementation Market Research Programs (MRP), vendor oversight, local literature review, etc.).
- Ensure the role of the German Information Officer (Informationsbeauftragter) is fulfilled: regulatory/compliance review of local promotional and non-promotional materials/activities according to all applicable laws, regulations, and National Codes of Conduct in Germany.
- Support Finance & Global Compliance with the reporting of transfers of value (ToV) into the national transparency registers (Sunshine Act).
- Work with commercial and market access to realize cross-functional objectives.
Link with global HQ will be established through a post-MA strategy team, lead by regulatory life-cycle mgmt. lead and with representatives of reg CMC, reg Ops, Med info, Med safety, Med compliance, Quality & Compliance, NPI, and Commercial. It’s main objective is to strategically coordinate and plan the life-cycle mgmt.
Who are you?
- You hold the legal diploma of 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.
- Able to coordinate activities in a matrix organization with internal stakeholders (local and HQ) and external vendors
- Knowledge of local pharmaceutical legislation and codes of conduct, and efficient communication to relevant local and global functions, including national competent authorities in the Germany.
- Specialist knowledge in the field of GDP to be able to fulfil the task of GDP-Responsible Person (preferred).
- Experience as coordinator of trainings for all in-country employees on Compliance, PV, Med Info, Quality & Regulatory procedures with support from relevant global functions.
- Knowledge of PV related activities (AE reporting, aRMM, PSP, MRP, vendor oversight).
- Experience with Regulatory review of (non-)promotional materials and events; qualification as an Information officer (Informationsbeauftragter) 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 German 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 German and English.
- Ability to drive initiatives without direct line management authority, to meet deadlines and set priorities.
What’s 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…!