Senior Expert/ Expert/ Senior Specialist Regulatory CMC

Posted 30 Mar 2020

Bangalore SBS, Karnataka - India

Req Id 205089

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.


Job Location- Electronic City, Bangalore

Job Details:

The Expert Regulatory Affairs CMC (RA-CMC) is responsible and accountable for driving assigned CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide and serves as the Regulatory Affairs CMC contact point and interface on interdisciplinary teams within Global Regulatory Affairs and other Functions.

Role is responsible for ensuring company compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Includes jobs which are not directly specialized in one of the other defined Regulatory Affairs job families or which are fully responsible for the whole functional area.

 

Experience: Minimum 9 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Global CMC regulatory experience

 

Education: Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

 

Job Specific Competencies & Skills

  • Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e Module 3, Module 2
  • Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations
  • Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
  • Practical experience in one of the following areas for synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
  • In-depth knowledge of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Experience with ROW countries a plus
  • Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
  • Good interpersonal skills and flexible mindset
  • Attention to details and Ability to think strategically
  • Ability to work in teams
  • Knowledge of Project management
  • Awareness of regulatory CMC affairs contribution to Pharma business
  • Good organizational and planning skills
  • Experience with people management within matrixed teams

 


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

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