RA Technology Product Specialist

Job Description Summary

As a member of a Technology Product team, the Technology Product Specialist contributes to the strategic vision of Regulatory Affairs and supports the digitalization of RA, by supporting the Technology Product Lead.
The Technology Product Specialist is accountable for managing operational activities related to Technology Products, understanding business benefits and taking appropriate actions in the product design, thereby supporting harmonization and continuous improvements.

 

Job Description

Major accountabilities:

• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Frequent internal company and external contacts.
• Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

• 3+ years of relevant industry experience
• Strong understanding and direct relevant experience with the data and technology landscape of pharmaceutical regulatory affairs and regulatory information management
• Good negotiation skills
• Excellent verbal and written communications

 

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance