International Program Regulatory Manager (IPRM)
- NOVARTIS
- 2 - 7 years
- Hyderabad
- 5 months ago
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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
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
Why Novartis:
You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion:
Accessibility and accommodation 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
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 player Experience in successful risk assessment, Organizational awareness
Why Novartis:
You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion:
Accessibility and accommodation 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
Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Corporate AffairsRole: Legal Management ConsultingEmployement Type: Full timeContact Details:
Company: NOVARTISLocation(s): Hyderabad+ View Contact
Keyskills: Procurement Networking Project management Pharmacy Risk assessment Diversity and Inclusion Biochemistry Representative Regulatory affairs Recruitment
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