Associate Director GRA - CMC Regulatory Intelligence China (location flexible in EU)
Merck
Aubonne, Switzerland
vor 5 Std.

A career at our company is an ongoing journey of discovery : our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics.

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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

You are responsible to give the ability for Company employees to acquire and apply knowledge and skills to fulfill best Patient expectations, to keep Control of the Chinese pharmaceutical Regulated Environment

Your Role : Drive interactions aiming at improvements of global CMC regulations and regulatory knowledge adoption with a specific focus on China

  • Coordinate and develop a consolidated position.
  • Lead specific Reg. CMC Intelligence Committee / Community (e.g QRAC, ATO, Trade association reps, pharmacopoeia )
  • Enable commenting, interpretation and risk analysis of CMC guidelines in collaboration with Regulatory Affairs' and other functions’ stakeholders
  • Perform surveillance on global CMC related regulatory requirements
  • CMC regulatory intelligence activities with a focus on implementation of global Health Authority requirements with priority on China

  • Develop knowledge management strategies to drive implementation of evolving regulatory requirements
  • Build Regulatory CMC knowledge foundation in close collaboration with CMC related departments and functions, e.g. update of country requirement database, author guides, template
  • Provide CMC regulatory advice and develop position papers to support the product development activities as well as CMC regulatory strategies
  • Develop and deliver internal and external training on CMC regulatory topics
  • Develop Strategic interactions and collaborative partnerships with Heath Authorities and Trade Associations with a specific interest with RDPAC

  • Represent Company in industry associations (main trade associations), expert groups and public conferences, workshops, congresses
  • Who you are :

  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree)
  • Minimum 8 years’ experience with strategic and business critical responsibilities related to CMC regulatory and / or related to CMC regulatory Intelligence in industry and / or as assessor in governmental institution
  • In-depth knowledge of global pharmaceutical legislation and CMC regulatory requirements
  • Awareness of regulatory affairs contribution to Pharma business
  • Experience in preparation, review and strategy of CMC regulatory documentation during clinical development and life-cycle management activities in at least two regions (e.
  • g. Europe, International would be an asset)

  • Practical experience in one of the following areas for biotech molecules : manufacturing process development, transfers, validation or analytical development and quality management
  • Excellent written and spoken communication skills in Chinese and English (knowledge of other European languages is an asset such as German)
  • 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!

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