A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: An exciting new opportunity has arisen to join our company as a Regulatory Compliance Specialist (all genders). In coordination with the all Site functions and Global HCQ CMC Regulatory and Global Regulatory Affairs, you ensure manufacturing and testing processes in Tres Cantos are in compliance with regulatory requirements (CMC section of registered dossiers, pharmacopoeias, etc.); you ensure commitments with Authorities are accomplished and followed up. In addition, you ensure every change to Site manufacturing and testing processes is assessed, implemented and communicated in the light of Company regulatory compliance process.
Finally, you ensure the renewal process of the Site GMP licence to operate in all registered Countries is progressed smoothly and a trustful relationship with the Spanish Health Authority is established.
Who you are:
- You hold an academic degree within Pharmacy, Chemistry, Science (or equivalent).
- You have minimum 5 years of experience in Regulatory Affairs, Regulatory Compliance or Quality Assurance in Healthcare industry.
- You have a good working knowledge of FDA, GMP, ISO and ICH regulations.
- You have good organizational skills and ability to multi-task, drive for results and make sound business decisions independently. As a person, you are good at building trust with stakeholders and you are able to establish a strong network internally in Merck as well as with our external partners.
- You accept travelling to the countries as a part of the job and you have a high proficiency in English.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com