摘要
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
About the Role
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: http://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. http://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:
http://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.