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Director CMC Regulatory Compliance Biologics

Posted 12 Feb 2018

Aubonne, Vaud - Switzerland

Req Id 169963

Details

A career 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.


Your role: Develop a best in class, fully integrated CMC Regulatory Compliance team. Provide leadership with a strong focus on behaviors that cultivate collaboration within quality organization and at interface with manufacturing and global regulatory affairs. Accountable for CMC regulatory activities i.e leading the dossier content and interaction with CMC technical functions of NBEs and LCM products. This encompass responsibility for the CMC section of the CMC strategy document and contribution to risk assessment, strategic support and advice. Accountable and responsible for translation and interpretation of the country regulatory requirements into CMC/technical requirements to provide them as prospective advice to the interdisciplinary CMC team. Secure CMC Regulatory Compliance for products handled in the group. Contribute to overall strategy, definition and adoption of Regulatory Compliance CMC standards/policies. Supervision for the creation of the quality reference files for the products handled in the group. Accountable for preparation of regulatory compliance audits at the sites, including CMOs. Provides profound expertise in pharmaceutical legislation and application of current regulatory landscape. Expert assessment of in-and out licensing projects for business development.

Who you are:

  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • Minimum of 10 years of pharmaceutical industry experience, with at least 5 years of global CMC regulatory experience
  • Strong people management and leadership skills with a focus on people
  • Broad knowledge of EU and US Pharmacopoeias and GMP regulations
  • English fluent

What we offer: 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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