CMC Regulatory Expert
1 day ago
The Chemistry, Manufacturing and Control (CMC) Manager will be responsible for leading global regulatory activities related to CMC for assigned projects/products.
Key Responsibilities:
- Develop and implement a global CMC regulatory strategy that balances innovation with compliance.
- Lead global CMC submission activities, including planning, authoring, reviewing, and coordination.
- Author and review high-quality CMC documentation for Health Authority submissions.
- Ensure technical congruency and regulatory compliance, meeting project timelines and e-publishing requirements.
- Prepare and communicate CMC Risk Management Assessments and contingency plans.
- Initiate and lead Health Authority interactions and negotiations as appropriate.
Requirements:
- Drug product experience is mandatory.
- Operations Management and Execution skills are essential.
- Ability to collaborate across boundaries.
- Project Management expertise.
Why Novartis?:
We reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. We achieve this through our people, who drive us each day to reach our ambitions.
Benefits of Working with Us:
- Opportunity to work on global projects.
- Collaborative and dynamic work environment.
- Competitive compensation and benefits package.
-
Cmc regulatory expert
1 day ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
-
Cmc Regulatory Expert
4 days ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team.This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities.The ideal candidate will have...
-
CMC Regulatory Expert
4 days ago
Hyderabad, Telangana, India beBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
-
CMC Regulatory Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 43,33,814 - ₹ 86,67,628Job Title: Chemistry, Manufacturing and Control Regulatory Expert-We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
-
CMC Regulatory Strategist
20 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000About Our CMC Regulatory Role:Seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to lead global CMC submission activities.Develop and implement strategic plans for global CMC regulatory submissions.Lead and manage global CMC submission projects.Author high-quality CMC documentation for health authority submissions.Ensure...
-
CMC Regulatory Expert
19 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Key Responsibilities:The ideal candidate will be responsible for finalizing CMC regulatory strategies for assigned products, including biological products.Develop and execute regulatory strategies by leading the development, review and approval of CMC submission components and documentation.Lead change control evaluation, preparation and submission of CMC...
-
CMC Regulatory Specialist
1 day ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,15,000Regulatory Expert for Chemistry, Manufacturing and ControlWe are seeking a skilled professional to lead global CMC submission activities.About the Role:This challenging position requires a strong understanding of regulatory requirements and technical expertise in chemistry, manufacturing, and control.Main Responsibilities:Develop strategic plans for global...
-
Global CMC Regulatory Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 17,00,000Job Title: Chemistry, Manufacturing and Control Regulatory SpecialistWe are seeking an experienced professional to lead our global Chemistry, Manufacturing and Control (CMC) regulatory strategy. This challenging role requires a strong understanding of regulatory requirements and the ability to develop and implement effective CMC submission activities.Main...
-
Cmc Regulatory Specialist
3 hours ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities.This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...
-
CMC Regulatory Specialist
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,00,00,000Regulatory Activities ManagerThis role is responsible for overseeing regulatory activities related to chemistry, manufacturing, and control (CMC) of products. Key tasks include preparing and publishing CMC documentation for submissions to Health Authorities, as well as interacting with HA's on CMC questions to support new product or post-marketed launches.
