Quality & Regulatory Manager - München, Germany

Job description

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 Quality and Regulatory Manager for Germany.

This position is based in Germany so you need to be living/ working in Germany and also speak fluent German. 

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.

You report into the Regulatory, Quality and Pharmacovigilance Director Germany.

Your role

  • Act as local single point of contact (SPOC) for global functions in Quality Assurance, Regulatory Affairs, Compliance and Pharmacovigilance
  • 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; 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.).
  • 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.

Job requirements

Who are you?

  • You have a University degree, preferably in Pharmacy and at least 5 years of pharmaceutical/biotech industry experience.
  • You hold the requirements for appointment as GDP responsible person acc. to AM-HandelsV §2 (1).
  • 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.
  • Experience as coordinator of trainings for all in-country employees on, for example, 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) is an added value.
  • Experience with Regulatory review of (non-)promotional materials and events is an added value. 
  • 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 in German and English.
  • Ability to drive initiatives without direct line management authority, to meet deadlines and set priorities.
  • As this position will intensively interact with the German authorities and stakeholders, you must have been living / working in Germany for some time. 
  • Flexibility to work in a hybrid setting: working remotely in Germany is possible, but also be flexible to travel to the office in München when needed.

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…!