Opportunity to work as Associate Regulatory CMC at Merck- Apply before 30th October 2023

Merck Group

Website Merck

About Merck

The Merck Group, commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, Germany. It boasts a workforce of approximately 60,000 employees and has a significant presence in 66 countries worldwide. The Merck Group encompasses a network of approximately 250 companies, with the primary entity being Merck KGaA in Germany.

Post: Associate Regulatory CMC

Job Description

  • Regulatory CMC Strategies: Develop and support regulatory CMC strategies and dossier preparation for Module 3 and Module 2.
  • Content Expertise: Possess comprehensive knowledge and experience in meeting regulatory CMC dossier content requirements (Module 3, Module 2).
  • Documentation Management: Prepare and manage regulatory CMC documentation, including international new product applications or variations.
  • Lifecycle Management: Experience in regulatory CMC lifecycle management is a valuable asset.
  • Technical Expertise: Practical experience in synthetic and/or biotech molecules, covering manufacturing process development, transfers, validation, analytical development, and quality management.
  • Global Regulatory Awareness: Stay informed about global pharmaceutical legislation, especially related to regulatory CMC aspects in ICH countries.
  • Communication Skills: Excellent written and spoken English communication skills (knowledge of other European languages, such as German, is advantageous).
  • Interpersonal Skills: Exhibit good interpersonal skills and adaptability.
  • Attention to Detail: Demonstrate meticulous attention to details.
  • Team Collaboration: Ability to work effectively in multinational teams.
  • Project Management: Awareness of project management principles.
  • Business Contribution: Understand the role of regulatory CMC affairs in contributing to the pharmaceutical business.

Candidate Profile

  • Educational Background: Hold a degree in a Life Science or related discipline, with a minimum of an MSc or equivalent degree; higher degrees, such as a PhD in a scientific discipline, are preferred.
  • Professional Experience: Require a graduate background with some to substantial relevant professional experience, along with solid knowledge and experience within the field and beyond.
  • Industry Experience: Minimum of 1-3 years of experience in the pharmaceutical industry.

Additional Information

  • Experience: 1-3 years
  • Qualification: Degree in a Life Science
  • Location: Bangalore
  • Industry Type: Pharma/ Healthcare/ Clinical research
  • End Date: 30th October 2023
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