Company Overview:
Merck is a global leader with over 63,000 employees across 65 countries, dedicated to addressing tough challenges in healthcare and sustainability. From personalized treatments to innovative scientific tools, the company drives advancements in life sciences, pharmaceuticals, and technology to transform life on Earth.
Position Details
Title: Senior Specialist – Regulatory CMC
Location: Bangalore – Electronic City
Industry: Pharma/Healthcare/Clinical Research
Department: Regulatory CMC
Job ID: 279980
Application Deadline: 20th December 2024
Key Responsibilities:
- Develop regulatory CMC strategies and dossiers (Modules 2 and 3).
- Prepare and manage regulatory CMC documentation, including for new product applications or variations.
- Engage in regulatory CMC life-cycle management activities.
- Provide expertise in synthetic or biotech molecule manufacturing, process development, validation, and quality management.
- Stay updated on global pharmaceutical legislation relevant to regulatory CMC.
Required Qualifications and Skills:
- Education: Bachelor’s or Master’s degree in Pharma, Biotechnology, or related fields.
- Experience:
- Comprehensive understanding of regulatory CMC strategies and dossier content.
- Hands-on experience with preparation and lifecycle management of regulatory documentation.
- Practical knowledge of synthetic or biotech manufacturing processes.
- Additional Skills:
- Proficiency in English (other European languages, like German, are advantageous).
- Strong interpersonal, project management, and attention-to-detail skills.
- Flexibility to work in multinational teams.
Application Details:
Interested candidates can apply for the position by visiting Merck’s career portal and referencing Job ID: 279980 before 20th December 2024.