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Senior Manager Pharma Assurance / Regulatory Affairs (m/f/d) Fulltime / Parttime in Venlo or Cologne

Netherlands, Limburg, VenloQuality Management & Continuous Improvement

Your Tasks

Shop Apotheke Europe is one of the fastest growing companies in the Venlo region. Let's grow together!

For our head office in Venlo or our location in Cologne we are looking for an enthousiastic:

Senior Manager Pharma Assurance/Regulatory Affairs (m/f/d) Fulltime / Parttime in Venlo or Cologne.

A challenging position in a fun team within an entrepreneurial and vibrant culture.

About the role

You will be co-responsible to build up a pharmaceutical enterprise with main focus on pharmacovigilance, quality and regulatory affairs. In this role you will report to the Associate Director Pharma Assurance.

Your tasks

  • You are responsible to build up both a quality management system and pharmacovigilance system and you make sure that those systems are aligned with the central quality system of Shop Apotheke.
  • You are responsible for registering pharmaceutical products and make sure that the products fulfill all compliant relevant aspects (label, SPC text, package leaflet, etc.).
  • You will design and guide both internal and external audits (e.g. pharma audits of manufacturers).
  • You are responsible to align with national and international pharmaceutical regulations in order to guarantee corporate compliance (GxP, Medical Device Regulation, etc.).
  • You play a key role in spreading a compliance and quality-oriented culture in our company.
  • You make sure that quality procedures are followed by the different departments and employees.
  • You will work in close collaboration with both our Legal and Quality department to ensure compliance with general and company regulations.

Your Profile

Your Profile

  • Educational background in Health Sciences, Pharmacy, Pharma Assurance, Natural Sciences, Quality Management or Legal studies.
  • Several years of experience in Pharma Assurance/ Regulatory Affairs.
  • Knowledge of Good Manufacturing Practices (GMP) compliance, pharmacovigilance and quality.
  • Excellent command of German and English.
  • Preferably experience with generics licensing, marketing authorization and market access.
  • Excellent communication skills across all levels of the organization.
  • Team player with an independent working style.

Your Benefits

  • Flexibility: Whether you need to cater for your family needs or you are simply looking for more flexibility in everyday life, we support you with flexible working hours.
  • Travel Allowance & Holiday Pay: In addition to your salary, we support your daily way to work with a travel allowance and you get holiday pay as well.
  • Sports Offers: To further boost your health, you can use our on-site fitness center as well as the external sports offer of Rodan Vitaal.
  • Onboarding: We make sure that you feel comfortable with us from day one.
  • Team- & Company Events: One team, one goal. Individual team events and regular company events are high on our list.
  • Training & Development: We encourage constant learning and growth through internal and external training and workshops.
  • Staff Canteen: Our staff canteen takes care of your culinary well-being. There are also free drinks available.
  • Employee Discount: We offer you discounts in our online shop.

About us

SHOP APOTHEKE EUROPE is an international e-commerce company with headquarters in the Netherlands, offices in Cologne & Berlin and further locations in Europe. As one of Europe's leading e-pharmacies with web shops in seven countries, we ensure that millions of people can rely on us for their health every day. We are growing extremely dynamically and are looking for more team players who want to continue this exciting development and the successful growth of the past years together with us!


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