REQ-10026354
Oct 20, 2024
Taiwan

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 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).

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:

  • Drug regulatory affair
  • Functional Breadth.
  • Cross Cultural Experience.
  • Operations Management and Execution.
  • Project Management.

Skills:

  • Pharmacisit preferred
  • Analytical Skill.
  • Collaboration.
  • Detail Oriented.
  • Lifesciences.
  • Project Planning.
  • Regulatory Compliance.

Languages :

  • English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Development
Innovative Medicines
Taiwan
Taipei
Research & Development
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10026354

(Sr.) Regulatory Affairs Specialist

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