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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