Cmc-ra Associate Ii

2 days ago

Bengaluru Karnataka, India AstraZeneca Full time

**Job Title: CMC RA Associate II**

**Introduction to role**:
Accountabilities:

- Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Support and deliver submission-ready packages to agreed timelines and manage information requirements.
- Ensure maintenance and filing of regulatory-related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant to information, regulations, and guidance from different regulatory agencies.
- Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.
- Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
- Give to the development and improvement of related business processes.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Share takeaways from own projects with colleagues/within functions.
- Conduct activities and interactions consistent with Things We Value and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- Drive business performance through continuous improvement by following processes, identifying problems, solving them, and implementing improvements.

**Essential Skills/Experience**:

- Educated to degree level/equivalent experience in a scientific field e.g., chemistry, pharmacy or biological science
- Minimum 7 years of relevant experience from biopharmaceutical industry, or other relevant experience
- Team working skills
- IT Skills
- Self-motivated
- Professional capabilities: Regulatory knowledge

**Desirable Skills/Experience**:

- Basic knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Experience in pharmaceutical production, regulatory affairs, quality assurance, R&D
- Basic understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Professional capabilities: Lean Approach, Quality Risk Management

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is where science meets innovation Join a team dedicated to pioneering new frontiers in Oncology with a vision to eliminate cancer as a cause of death. With pioneering science fused with the latest technology, we aim to deliver breakthroughs backed by investment. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Be empowered to lead at every level, take smart risks, and contribute to improving millions of lives.

  • Cmc-ra Associate Ii

    3 days ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title CMC RA Associate II Introduction to role Are you ready to make a significant impact in the world of Chemistry Manufacturing and Control CMC documentation As a CMC RA Associate II you ll be at the forefront of supporting submissions for both original marketing applications and the maintenance of existing licenses for marketed products Join...

  • Global Cmc Regulatory Associate

    2 days ago

    Bengaluru, Karnataka, India Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • ▷ Immediate Start! Cmc Regulatory Affairs Associate Director Ii

    1 week ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title CMC Regulatory Affairs Associate Director IIGlobal Career Level EIntroduction to roleAre you a strategically focused Regulatory CMC professional eager to play an integral part in bringing life-changing medicines to patients If so please read on As a CMC Regulatory Affairs Associate Director II you will provide essential CMC Regulatory Strategy ...

  • Global CMC Regulatory Associate

    3 days ago

    Bengaluru, Karnataka, India Eli Lilly Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate/ Senior Associate

    3 weeks ago

    Bengaluru, Karnataka, India Eli Lilly Full time

    At Lilly we unite caring with discovery to make life better for people around the world We are a global healthcare leader headquartered in Indianapolis Indiana Our employees around the world work to discover and bring life-changing medicines to those who need them improve the understanding and management of disease and give back to our communities...

  • International Cmc Regulatory Affairs Associate

    7 hours ago

    Bengaluru, Karnataka, India AstraZeneca Full time

    **Job Title - Associate - International CMC Regulatory Affairs** **Career Level - C** Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get...

  • Expert Regulatory CMC

    7 days ago

    Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Your Role:Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as...

  • Expert Regulatory Cmc

    2 days ago

    Bengaluru, Karnataka, India Merck KGaA Full time

    Job Id 291455 - Bangalore, Karnataka, India - Job Type Full-time 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....

  • Associate Manager –global Cmc Regulatory

    3 weeks ago

    Bengaluru, Karnataka, India Elanco Full time

    At Elanco NYSE ELAN - it all starts with animals As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets Were driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the...

  • Expert Regulatory CMC

    2 weeks ago

    Bengaluru, India Merck Healthcare Full time

    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...