Key responsibilities:

• Providing input into registration strategies for INT countries and drives the execution of registration plans as defined in the INT RA subteam and in partnership with the countries, regional roles and global line functions as applicable including procurement of ancillary documents for submission dossier, contribution to responses to Health Authority (HA) questions, follow up on key milestone activities by relevant RA and line function stakeholders.
• Supporting the IPRD in partnering with DU RA roles to obtain, digest and communicate efficiently pipeline information to relevant stakeholders.
• Ensures updates to registration plans are performed timely and with the necessary quality.
• Supporting the IPRD in the execution of plans for Emerging Markets Brands for assigned projects.
• Assisting the IPRD in the execution of registration plans for products that target diseases which are predominantly prevalent in INT countries.
• Partnering the IPRD in the execution of geographic expansion plans for INT countries.
• Driving the dissemination of information to and education of global roles on INT country/regional requirements.
• Advancing the implementation of functional or cross-functional initiatives, particularly those with potential impacts on INT RA resources or FTE allocations.

Essential Requirements:

• Experience in Regulatory affairs in a country, regional or global regulatory setting.
• Experience in regulatory license maintenance and new product registrations
• Ability to work in cross-functional environment.
• Experience in project management.
• Highly committed and team oriented.
• Ability to recognize potential regulatory issues, complex situations, sound risk assessment and overcoming hurdles.
• Strong team player.

Commitment to Diversity and Inclusion/EEO

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