Head of Regulatory CMC Large Molecules Development
Company: Merck KGaA
Posted on: June 9, 2021
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.
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
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
- Excellent written and spoken communication skills in English
(knowledge of other European languages is an asset such as
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
Keywords: Merck KGaA, Billerica , Head of Regulatory CMC Large Molecules Development, Other , Billerica, Massachusetts
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