Sr Associate IS Analyst - docuBridge Amgen Technology Private Limited

5.0 - 9.0 years

2 - 6 Lacs

Hyderabad, Telangana, India

On-site

Role Overview The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements. Roles & Responsibilities Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with g...

Posted 1 month ago

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Sr Associate IS Engineer Amgen Technology Private Limited

5.0 - 9.0 years

2 - 6 Lacs

Hyderabad, Telangana, India

On-site

Role Overview The Sr. Associate IS Engineer CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation. Roles & Responsibilities Design, develop, and ...

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Life Science : Submissions Publisher : Apply Now Outpace Consulting Services

2 - 6 years

7 - 10 Lacs

Hyderabad, Bangalore Rural, Mumbai (All Areas)

Work from Office

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission ...

Posted 4 months ago

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