International Program Regulatory Manager

Job Description Summary

The International Program Regulatory Manager (IPRM) works under supervision of the International Program Regulatory Director (IPRD) and in partnership with international regulatory teams and global line functions to provide input into registration strategies and to drive the timely execution of registration plans for the assigned portfolio in the assigned International (INT) countries. They are accountable to recognize and resolve high priority topics to ensure timelines and objectives of registration plans are met.
The IPRM uses global, regional and country sources to maintain the relevant databases on country requirements, pipeline information and registration plans across all INT markets and to disseminate relevant information to INT stakeholders. The IPRM supports and implements initiatives to enhance efficiency in ways of working and functional excellence.
The IPRM may act as deputy of the IPRD on global RA sub teams. The IPRM may contribute to regional cross-functional initiatives

Job Description

Key Responsibilities

• Provides 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. Maintain up to date contact country contact lists for programs and countries in scope.
• Supports 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
• IPRM supports and implements initiatives to enhance efficiency in ways of working and functional excellence.
• Supports the IPRD in the execution of plans for Emerging Markets Brands for assigned projects.
• Supports the IPRD in the execution of registration plans for products that target diseases which are predominantly prevalent in INT countries.
• Supports the IPRD in the execution of geographic expansion plans for INT countries.
• Drives the dissemination of information to and education of global roles on INT country/regional requirements.
• Support the implementation of functional or cross-functional initiatives, particularly those with potential impacts on INT RA resources or FTE allocations.
• May act as deputy of IPRD on assigned programs

Minimum Requirements :

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• Minimum of 2 years 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 playerExperience in successful risk assessment, Organizational awareness

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

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