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GRA CMC Expert - Biosimilar NBE products development

Posted 09 Aug 2017

Aubonne, Vaud - Switzerland

Req Id 166002


A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

2 years limited contract with possible extension

The GRA-CMC is accountable to ensure that assigned products are developed in line with global CMC regulatory requirements of all target countries and CMC regulatory document are suitable for submission. This role reports directly to the Head of GRA-CMC and works in close collaboration with the GRA CMC function from our partner Fresenius.

Your role: Contribute to develop appropriate CMC regulatory strategies for assigned Biosimilar development projects. Assure assigned products from a CMC perspective are developed in line with global regulatory requirements of all target countries and that protocol & report are suitable for regulatory dossier authoring. Represent MERCK CMC regulatory affairs in cross-functional & cross-company project team. Support cross-functional regulatory projects (e.g. briefing documents, CTAs, INDs) in a proactive, engaging and efficient way, in joint collaboration with partner (Fresenius) by reviewing dossier and ensuring suitability of submission. Whenever required, be involved to provide advice to answer objection from HAs. Consult and inform line manager of status, issues, risks, and proposed solutions as appropriate timely and appropriately. Compile presentations and reports to line manager and management functions. Lead interactions with partners for specific responsibility (e.g by performing Reg compliance Audit, Regulatory assessment and submission for new product implementation…)

Who you are

  • You have a Degree in Pharmacy, Chemistry, Biology, Biotechnology or equivalent, PhD preferred.
  • You have 5-10 years experience in regulatory affairs, research and development or quality assurance/compliance.
  • You have Knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets
  • You have the Ability to effectively communicate and summarize complex issues verbally and in writing
  • Ability to work independently and focus on multiple issues / deadlines simultaneously
  • Experience working within a global team framework and a multi-cultural environment
  • You are fluent in English

What we offer: At Merck, 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!

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