Merck Life Sciences Associate Job – Apply Now
Associate Regulatory CMC For Life Sciences
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Job Title: Associate Regulatory Affairs CMC
Job Location: Electronic City Phase 1, Bangalore
The Associate Regulatory Affairs CMC (RA-CMC) is responsible for and contributes to driving assigned CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide. The role is responsible for ensuring companies compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
Key Responsibilities:
- Develop regulatory CMC strategies and CMC dossiers
- Prepare and manage regulatory CMC documentation
- Contribute to regulatory CMC life-cycle management activities
- Provide expertise on synthetic molecules and/or biotech molecules manufacturing processes
- Ensure compliance with global pharmaceutical legislation
Requirements:
- Graduate degree in Life Science or related discipline (minimum MSc or equivalent degree)
- Minimum 1-3 years of pharmaceutical industry experience
- Comprehensive knowledge and experience with regulatory CMC strategies and dossier content requirements (Module 3, Module 2)
- Experience in international new product applications or variations
- Practical experience in manufacturing process development, transfers, validation, analytical development, or 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
- Good interpersonal skills and flexible mindset
- Awareness of project management and regulatory CMC affairs contribution to Pharma business
What we offer: We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
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