Job Description
Vacancy for Associate Regulatory at Merck 2023.
| Organization | Merck |
| Post Name | Associate Regulatory CMC |
| Job Location | Bangalore |
| Official Website | https://www.merckgroup.com/en |
Job Title/Position:
Associate Regulatory CMC
Job Overview:
Job vacancy for
Job Location:
Bangalore
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What are the Key Responsibilities?
- Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2
- Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e. Module 3, Module 2.
What are the Educational Qualification(s) for Associate Regulatory?
Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyond.
What is the Experience Required for this Job?
- Minimum 1-3 years of pharmaceutical industry experience
- Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations
- Experience with regulatory CMC life-cycle management activities would be an asset
What are the Preferred Skills required for this Job/Position?
- Practical experience in one of the following area synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
- Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries.
- 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.
- Ability to work in multinational teams.
- Awareness of Project management
- Awareness of regulatory CMC affairs contribution to Pharma business
Related:
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- Vacancy for Statistical Programmer at Cliantha Research 2023
- Vacancy for Project Associate at Regional Centre for Biotechnology 2023
- Vacancy for Research Associate at Jubilant Biosys Ltd 2023
- Vacancy for Project Associate at PGIMER 2023
- Vacancy for Technical Officer at WHO India 2023
- Vacancy for Project Research Associate in WHO TDR Project RMRC 2023
Detailed notice
https://jobs.vibrantm.com/merck/job/Bangalore-Associate-Regulatory-CMC-Karn-560100/979776201/
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