Associate Submission Manager

Manage activities associated with the preparation of non-oncology Investigator Brochure (IB) annual updates within Biomedical Research (BR) in compliance with internal SOP and health authority requirements.Organizing and chairing the kick-off meeting to establish the level of update and contributors across Biomedical Research Translational Medicine and...

Manage activities associated with the preparation of non-oncology Investigator Brochure (IB) annual updates within Biomedical Research (BR) in compliance with internal SOP and health authority requirements. Organizing and chairing the kick-off meeting to establish the level of update and contributors across Biomedical Research Translational Medicine and...

Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) forNew Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/...

Position Title : Submission Manager About The Role Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for New Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental...

Position Title : Submission ManagerAbout The RoleResponsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for- New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/...

Hyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...

Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...

Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...

Position Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...

Position Title : Senior Transparency Associate About the role : Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of...

Regulatory Affairs AssociateAround 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...

Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...

When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...

As a Clinical Research Associate, you'll play a pivotal role in ensuring the successful execution of clinical trials. From monitoring trial progress to ensuring regulatory compliance and participant safety, you'll be at the forefront of cutting-edge medical research.Key Responsibilities:- Conduct site visits to monitor trial activities and ensure compliance...

Your responsibilities include but not are limited to:• Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or...

Responsibilities Support core financial planning processes (Month-end closing, Forecast, AOP, etc.) through data collection, verification and processing, to ensure timely submission to GBS and Sector, looking for automation, digitalization and streamlining of current processesWork closely with Finance and Non-Finance stakeholders (Sales Finance, Supply...

Regulatory Affairs LabelingBachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI,...