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Expert/Senior Expert Regulatory CMC

 

A career at our company is an ongoing journey of discovery: our 60,300 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.

 

Your Role:

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.

 

Who you are:

Experience: Minimum 9 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 5 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 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

 

Job Location: Electronic City Phase 1 - Bangalore

 

 

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

 

Job Requisition ID:  243702
Location:  Bangalore
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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