Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125 000 people of more than 140 nationalities work at Novartis around the world.

Job Summary

The purpose of the role is to ensure timely registration and maintenance of new and approved drug products in order to ensure viability of these products in the market place as well as to maintain the available regulatory databases and ensure compliance. The role holder will also interact with Health Authorities to support new product or post marketed launches.

Major accountabilities

• New Product Registrations: prepare local dossiers for submission with drug registration applications in a timely manner and follow-up of the application during the evaluation phase to achieve a favorable outcome.
• Maintenance of registered products: maintain the registration of currently approved products by submitting variations and re-registrations.
• Maintaining regulatory databases with up to date and accurate information of products.
• Relationship with Distributors: ensure all registration documents required for importation of products are provided to distributors to ensure compliance.
• Relationships outside the company: develop and maintain good working relationships with local Health Authorities and other stakeholders.
• Provide timely feedback from Health Authorities while following up on submissions made to the Health Authorities.
• Ensure pharmacovigilance compliance by informing Health Authorities of all relevant safety updates through timely submissions of safety information.
• Submission and follow up of promotional materials and advert approval requests with Health Authorities.
• Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Review high-quality CMC documentation for Health Authorities submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency.
• Prepare and communicate RA risk, contingency plans, and lessons learned on major submissions and escalate to management as appropriate.
• Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing and coordinating Health Authority pre- submission meetings as and when needed.

Key Performance Indicators

• The timely registration of new drug products and renewal of license of approved products and when due.
• Accurate maintenance of registered products database.
• No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within local RA control.
• Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders.
• Ensure regulatory submitted documentation follows Novartis guidelines and meets regulatory guidelines.
• Provides high quality regulatory evaluation and strategic advice on time, regulatory compliance met in all compliance systems.
• Maintains collaborative partnerships with stakeholders.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Operations Management and Execution
• Project Management
• Collaborating across boundaries
• Cross Cultural Experience
• 3-4 years relevant experience
• Pharmacist with experience in regulatory affairs
• English speaking

Division: Global Drug Development

Business Unit : REG AFFAIRS GDD

Company/Legal Entity : Novartis Pharma Services AG

Functional Area : Research & Development