Summary
-Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
About the Role
Major accountabilities:
- Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
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Key performance indicators:
- Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines
Minimum Requirements:
Work Experience:
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
Skills:
- Analytical Skill.
- Clinical Trials.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.
Languages :
- English.
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Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No