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Head of Regulatory CMC Large Molecules Development

Company: Merck KGaA
Location: Billerica
Posted on: June 9, 2021

Job Description:

A career at our company is an ongoing journey of discovery: our 57,000 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.

Your Role:

The Global Regulatory Affairs CMC Group lead is accountable for strategic oversight of the assigned GRA-CMC group of experts, through inspirational leadership and expertise. This role reports directly to the Head of GRA-CMC and collaborates and partners with other Merck functions and other pharmaceutical companies in the context of Trade and Regulatory Associations.This role supports the CMC Regulatory strategy and Health Authority interactions.

  • Endorse the global CMC-part of the regulatory strategy (RSD) for the products under his/her responsibility. This encompasses risk assessment, strategic support and advice.
  • Support Health Authority interactions on CMC issues and lead in case of critical submissions
  • Setting GRA-CMC objectives at a group level in alignment with the relevant stakeholders
  • Collaboration with stakeholders on a management level, e.g., GRA and technical function leadership teams as per scope of accountability, supervisory committees of partners, regulatory authority senior managers
  • Endorse the CCP regulatory assessment, country specific CMC regulatory requirements and the regulatory strategy and risks of proposed regulatory submissions in the CMC area

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)

  • Experience in leading teams within a matrixed organization

  • Minimum of 12 years of pharmaceutical industry experience, with at least 6 years of global CMC regulatory experience

  • Strong people management and leadership skills at a group level with a focus on building consensus through negotiation and best practices

  • Excellent written and spoken communication skills in 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!

Curious? Apply and find more information at

Keywords: Merck KGaA, Billerica , Head of Regulatory CMC Large Molecules Development, Other , Billerica, Massachusetts

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