Location: Bangalore – Electronic City
Industry: Pharma/Healthcare/Clinical Research
Functional Area: Regulatory CMC
Job ID: 279980
Application Deadline: 10th November 2024
About Merck
At Merck, our passion for science and technology drives our team of approximately 63,000 employees across 65 countries. We tackle some of today’s most pressing challenges and strive to create sustainable solutions that improve and prolong lives. From personalized treatments for serious diseases to empowering the scientific community with innovative tools and services, our commitment to enhancing health is unwavering.
Job Description
We are seeking a Regulatory CMC Senior Specialist to join our dynamic team. In this role, you will:
- Develop and support regulatory CMC strategies and dossiers (Module 3, Module 2).
- Prepare and manage regulatory CMC documentation for international new product applications or variations.
- Engage in regulatory CMC life-cycle management activities.
- Utilize practical experience in synthetic or biotech molecules, focusing on manufacturing process development, validation, and quality management.
- Stay informed about global pharmaceutical legislation related to regulatory CMC, particularly within ICH countries.
- Collaborate effectively in multinational teams, demonstrating excellent written and spoken communication skills in English (additional European languages like German are a plus).
Key Responsibilities
- Understand and develop regulatory CMC strategies.
- Ensure accurate and timely submission of CMC documentation.
- Collaborate with cross-functional teams to facilitate product development.
- Maintain attention to detail and exhibit a flexible mindset in problem-solving.
Qualifications
- Comprehensive knowledge and experience in developing regulatory CMC strategies and dossier content.
- Experience with regulatory CMC documentation and life-cycle management.
- Strong interpersonal skills and ability to work collaboratively in diverse teams.
- Project management awareness.
Why Join Us?
At Merck, you’ll be part of a mission-driven organization that values innovation and collaboration. You will have the opportunity to contribute to groundbreaking projects that impact lives globally.
Apply Now!
If you’re ready to take the next step in your career and make a difference in the world of healthcare, submit your application by 10th November 2024.