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Senior Manager CMC Regulatory Compliance (m/f)

Posted 08 Mar 2018

Darmstadt, Hesse - Germany

Req Id 173257

Details

A career is an ongoing journey of discovery: our 52,000 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:

You lead CMC regulatory activities like leading the dossier content and interaction with CMC technical functions for concerned molecules of specific focus area (life cycle management). This encompass responsibility for the CMC section of the CMC strategy document and contribution to risk assessment, strategic support and advice. You are accountable and responsible for translation and interpretation of country regulatory requirements into CMC/Technical requirements to provide prospective advice to the interdisciplinary CMC team as well as identifying potential pharmaceutical issues and risks, contribute to risk mitigation and solution of issues in close collaboration with corresponding functions. You will participate in Change Control Procedures according to the current pharmaceutical requirements and systems and processes for CMC Dossier approvals.

You should ensure CMC Reg Compliance for products handled in the group. Responsible for the creation of the quality reference files for products handled in the group and you will be responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs. 

You are responsible for commenting, interpretation and implementation of CMC relevant laws, directives, guidelines and pharmacopeias.

Who you are:

  • You have a University Degree preferably with PhD in Pharmacy `Approbation zum Apotheker' or Chemistry
  • Expert assessment of in-and out licensing projects for business development (Due Diligence)
  • You have specific experience in the field of marketing authorizations, ICH and GMP guidelines, Document Management Systems
  • Profound expertise in pharmaceutical legislation and application of current regulatory landscape including pharmacopeia requirements for the pharmaceutical areas
  • You have excellent communication skills and fluent in spoken and written English


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

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