Regulatory Submissions jobs in Telangana
Explore 11 current openings. Compare roles, companies, locations, and work options, then open any job to view the full details.
Current openings
Showing 20 jobsRegulatory Submission Operations Specialist
Regeneron PharmaceuticalsRegulatory Submission Operations team at Regeneron India ensures timely, compliant MHRA Clinical Trial Authorization submissions via the IRAS portal. The Specialist completes and uploads CTA applications, manages …
Hyderabad,IN,IndiaHybridFull-timeActiveGlobal Regulatory Submission Manager
NovartisNovartis’ Regulatory Affairs team in Hyderabad drives cross‑functional projects to plan, compile and dispatch worldwide regulatory submissions. The role manages multiple global eCTD and non‑eCTD dossiers (NDA/BLA/IND, …
Hyderabad,IN,IndiaOn-siteFull-timeActiveIS Organizational Effectiveness Manager – Regulatory Structured Submission
AmgenFacilitate Scrum events for Regulatory Structured Submissions Team, enhance communication, manage risks, drive continuous improvement, adapt SAFe principles, lead product delivery, prioritize backlog, define acceptance …
Hyderabad, IndiaOn-siteFull-timeActiveSenior Manager Regulatory Submission Operations
Regeneron PharmaceuticalsRegulatory Submission Operations team at Regeneron drives the end‑to‑end delivery of clinical trial authorisation submissions via the IRAS portal. The Senior Manager leads a team of specialists, oversees quality, RFI …
Hyderabad, IndiaHybridFull-timeActiveGlobal Regulatory Submission Manager
NovartisEnsures controlled documentation, record retention, and compliance with global regulatory agencies. Manages complex submission projects, develops strategy, supports global systems, resolves issues creatively, and …
Hyderabad, Telangana, IndiaOn-siteFull-timeActiveSpecialist - Submission Management
Bristol-Myers Squibb CompanySpecialist in Submission Management at Bristol‑Myers Squibb supports regulatory teams in Hyderabad by tracking, collecting, and reviewing all components for routine submissions to health authorities. The role involves …
Hyderabad, TS, IndiaOn-siteFull-timeActiveAssociate GRAAS Operations
AmgenGlobal Submission & Information Management (GSIM) at Amgen is the backbone of regulatory data flow, ensuring compliant, timely submissions across global sites. The Associate GRAAS Operations role monitors data quality, …
Hyderabad,IndiaFull-timeActiveRegulatory Affairs Specialist
MedtronicRegulatory Affairs Specialist at Medtronic drives compliance for design, development, and regulatory submissions. Leads coordination of document packages for global submissions, renewals, and inspections. Recommends …
Nanakramguda, Hyderabad, IndiaHybridFull-timeActiveSr Associate Software Engineer – Regulatory Structured Submission
AmgenAutomate regulatory content via VBA on GxP platform. Create and enhance VBA macros and user interfaces. Implement robust error handling and debugging. Document code and processes for maintainability. Collaborate with …
Hyderabad, IndiaOn-siteFull-timeActiveSpecialist, Submission Management
Bristol-Myers Squibb CompanyWorking with us at Bristol‑Myers Squibb, you’ll manage regulatory submissions, track components, troubleshoot issues, prepare FDA forms, verify eCTD compliance, update RIM system, coordinate with international teams, …
Hyderabad, TS, IndiaOn-siteFull-timeActiveSenior Associate IS Analyst
AmgenAutomate regulatory content on GxP platform using VBA, design MS Office interfaces, implement robust error handling, document code, test and validate changes, collaborate with regulatory experts, provide technical …
Hyderabad, IndiaOn-siteFull-timeActiveRegulatory Affairs Manager
MedtronicMedtronic seeks a Regulatory Affairs Manager to lead regulatory submissions, license renewals, and compliance initiatives across the organization. The role involves coordinating document packages for regulatory …
Nanakramguda, Hyderabad, IndiaHybridFull-timeActiveAssociate IS Business Systems Analyst
AmgenJoin Amgen’s mission to serve patients. As an Associate IS Business Systems Analyst, you’ll lead Scrum events for the Regulatory Structured Submissions Team, enhancing communication, aligning with program goals, and …
Hyderabad, IndiaOn-siteFull-timeActiveGDO Submission Document Senior Specialist
Bristol-Myers Squibb CompanyGDO Submission Document team ensures clinical submission deliverables meet quality and regulatory standards. The Senior Specialist partners with the Submissions Document Manager, drives development of protocol-related …
Hyderabad,IN,IndiaOn-siteFull-timeActiveRegulatory Affairs Specialist
MedtronicRegulatory Affairs Specialist at Medtronic responsible for coordinating regulatory submissions, preparing document packages, leading material compilation for submissions, license renewals, and annual registrations, …
Nanakramguda, Hyderabad, IndiaHybridFull-timeActiveRA CMC Senior Submission Coordinator
NovartisThe RA CMC Senior Submission Coordinator will independently manage complex CMC submissions, ensuring regulatory compliance and timely delivery. Responsibilities include QC and DA checks, eCTD documentation, database …
Hyderabad, IndiaOn-siteFull-timeActiveRegulatory Affairs Specialist
Lonza GroupLonza’s Global Capability Center (GCC) in Hyderabad builds global regulatory submissions for clinical trials and product lifecycle. The Regulatory Affairs Specialist writes CMC dossiers, manages Veeva workflows, and …
Hyderabad,IndiaOn-siteFull-timeActiveRegulatory Affairs Mgr
AmgenRegulatory Affairs Manager at Amgen leads international regulatory strategy for biotech and oncology products. Oversees global regulatory submissions, including clinical trials, marketing authorizations, and lifecycle …
Hyderabad, IndiaOn-siteFull-timeActiveRegulatory Affairs Specialist
Lonza GroupLonza’s Global Capability Center (GCC) in Hyderabad drives global regulatory submissions. As a Regulatory Affairs Specialist (CMC), you write and manage CMC dossiers for clinical trials, oversee Veeva workflows, and …
Hyderabad,IndiaOn-siteFull-timeActiveR&D Submission & Document Services Lead
SanofiHead of R&D Submission & Document Services at Sanofi’s Hyderabad Hub, driving regulatory excellence by leading a diverse team of submission and document specialists. The role focuses on ensuring timely, high‑quality …
Hyderabad,IndiaFull-timeActive