Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Global Regulatory Submission Manager
Job Description
• Manages multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]
• Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions.
• Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows.
• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals.
• Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives.
• Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs.
• Assesses publishing resource and support needs and develops/implements solutions to create efficiencies.
• Organizes, leads and facilitates and or participates in meetings with internal and external stakeholders (including acquisitions, partnerships and divestiture efforts).
Candidate Profile
1. Masters Degree in Science or Pharmacy with Minimum 5 years to 8 years of relevant experience in publishing/Regulatory Operations
2. Experience with global regulatory submission formats, including familiarity with submission publishing activities
3. Ability to plan and priorities workload
4. Ability to work in a matrix environment
5. Ability to build effective relationships across teams
6. Active command in English with excellent written and spoken communication skills
7. Good knowledge of Regulatory tools.
8. Adequate knowledge of software and computer tools.
9. Creative thinking and effective interdisciplinary collaboration with other functions.
Additional Information
Experience : 5+ year
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 25th July, 2019
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