5.0 - 10.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Regulatory Affairs Labeling Specialist role Key Responsibilities: ? Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. ? Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. ? Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information. ? Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions. ? Responsible for SPL Preparatio...

Posted 2 weeks ago

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Sr. Associate Labelling Amgen

2.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

As a Senior Associate in Labeling Compliance, you will play a crucial role in planning, coordinating, and executing global labeling compliance initiatives within the Regulatory Affairs department. Your responsibilities will include: - **Labeling Strategy and Execution** - Coordinate day-to-day labeling activities to ensure compliance with global regulatory requirements. - Act as a key contact for cross-functional teams, offering guidance on labeling procedures, formats, and timelines. - Execute labeling change requests, monitor progress, and maintain accurate documentation in labeling management systems. - **Cross-functional Collaboration in a Matrix Organization** - Collaborate with global ...

Posted 2 weeks ago

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Label Manager Biocon Biologics

10.0 - 15.0 years

0 Lacs

karnataka

On-site

The primary responsibility of this role is to develop a Labeling Strategy for health authority interactions and address labeling queries from Health Authorities or Country Organizations related to assigned programs/products. This includes ensuring proper Artwork Management for activities such as Initial Submission and Commercial Launch in coordination with the Cross-Functional Team. Additionally, you will be responsible for reviewing Promotional Materials and participating in Cross-Functional Team meetings to provide Regulatory input on strategic decisions and ensure compliance with regulations to avoid any misleading information. You will also be tasked with coordinating with External Vendo...

Posted 1 month ago

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Labeling Specialist Biocon Biologics

5.0 - 10.0 years

0 Lacs

karnataka

On-site

As a Regulatory Affairs Labeling Specialist, you will be responsible for creating a labeling strategy for health authority interactions and handling labeling queries from Health Authorities (HA) or Country Organizations (CO) for the assigned program/products. Your key duties will include ensuring artwork management for initial submissions/commercial launch activities in coordination with the Cross-Functional Team (CFT). Additionally, you will participate in the review of promotional materials and represent Regulatory in CFT meetings to make strategic decisions ensuring no misleading information is provided. You will also be responsible for coordinating with external vendors to prepare/review...

Posted 2 months ago

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Sr. Associate: Labelling Amgen Technology Private Limited

4.0 - 6.0 years

4 - 6 Lacs

Hyderabad, Telangana, India

On-site

Overview In this pivotal role, you will support the planning, coordination, and execution of global labeling compliance initiatives within the Regulatory Affairs department. Working in a fast-paced, matrixed environment with no direct reports, you will collaborate extensively with cross-functional and regional teams including Regulatory Affairs, Quality, Operations, and Supply Chain to ensure that labeling meets all global regulatory requirements and maintains the highest standards of quality. This position offers a unique opportunity to lead initiatives, contribute to strategic projects, and drive continuous improvement, all while building strong partnerships across the organization. Key Re...

Posted 3 months ago

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