Senior Specialist - Regulatory CMC

Work Your Magic with us! 

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.
 

Title: Senior Specialist – Regulatory CMC

Location: Bangalore – Electronic City

Job Specific Competencies & Skills:

• 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.
• 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.
• 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.

We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.
 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. 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!

Apply now and become a part of our diverse team!