摘要
About the Role
Major accountabilities:
- Leads implementation of the defined global and regional registration strategy into country submissions.
- Coordinates, plans and prepares for submission of initial registrations and post approval applications.
- Lead regulatory activities during HA reviews, responding to questions and HA interactions.
- Create/ Supervise in the creation, maintenance, review & approval of artworks in line with the approved information by the HAs in the artwork management system
- Review, approval of Promotional and Non-Promotional Material for assigned products according to Novartis policy and guidelines and applicable local regulation, submission to HAs when applicable.
- Ensure compliance with local regulation and adherence to Global and local processes during daily regulatory activities:
- Ensures timely RA input and monitoring of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and documenting Regulatory Information Management systems.
- Manage/ Support HA inspections, global GMP & PV audits, self-assessment, deviations, quality events and respond adequately to all requests about regulatory area.
Key performance indicators:
- The timely registration of new drug products, line extensions, new indications.
- Accurate & timely maintenance of products life cycle management.
- Good governance and Oversight of third parties KPIs
- Compliance of the promotional materials with the registered/approved PI.
- High regulatory compliance percentage for all relevant databases.
- Keep the relation with all related parties (inside & outside NVS) at the top level of respect, confidence & reliability.
Minimum Requirements:
Work Experience:
- Pharmacist with 5-7 years of experience in Regulatory Affairs.
- An experience in similar position with management is desired.
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
Skills:
- Registration strategies
- Detail Oriented.
- Drug Development.
- Lifesciences.
- Negotiation Skills.
- Regulatory Compliance.
Languages :
- English is a must
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