393606BR
Mar 05, 2024
India
About the Role
Your responsibilities include, but are not limited to:
• Manages multiple and simultaneous global regulatory submission projects in
eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA
AtoQ, Compliance submissions, etc.].
• Drives cross-functional teams focused on the planning, compilation and dispatch
of worldwide regulatory submissions, anticipating technical obstacles and
developing solutions.
• Provides guidance to project teams related to worldwide HA submission
structure at/requirements, submission filing strategy, eCTD document
lifecycle management and submission compilation workflows.
• Tracks timely delivery of submission components, coordinates submission
publishing activities with publishing team and organizes internal review and
approvals.
• Partners with cross functional groups across the organization and contributes to
operational activities and ongoing initiatives.
• Effectively troubleshoots technical/quality issues relating to compilation,
validation and dispatch of global submission outputs.
• Assesses publishing resource and support needs and develops/implements
solutions to create efficiencies.
• Organizes, leads and facilitates and or participates in meetings with internal and
external stakeholders (including acquisitions, partnerships and divestiture
efforts).
• Manages multiple and simultaneous global regulatory submission projects in
eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA
AtoQ, Compliance submissions, etc.].
• Drives cross-functional teams focused on the planning, compilation and dispatch
of worldwide regulatory submissions, anticipating technical obstacles and
developing solutions.
• Provides guidance to project teams related to worldwide HA submission
structure at/requirements, submission filing strategy, eCTD document
lifecycle management and submission compilation workflows.
• Tracks timely delivery of submission components, coordinates submission
publishing activities with publishing team and organizes internal review and
approvals.
• Partners with cross functional groups across the organization and contributes to
operational activities and ongoing initiatives.
• Effectively troubleshoots technical/quality issues relating to compilation,
validation and dispatch of global submission outputs.
• Assesses publishing resource and support needs and develops/implements
solutions to create efficiencies.
• Organizes, leads and facilitates and or participates in meetings with internal and
external stakeholders (including acquisitions, partnerships and divestiture
efforts).
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• 3-5 years of Regulatory Affairs or Regulatory submission related experience. Experience with global regulatory submission formats, including familiarity with submission publishing activities.
• Familiar with the drug development process
• Effective interpersonal skills, strong written and oral communication and
presentation skills.
• Solid project management, organizational and time management skills to manage
multiple ongoing projects simultaneously.
• Familiar with global Health Authority regulations/guidances eg., FDA regulations,
ICH and EMA guidelines/directives. Works independently and with minimal supervision.
• Proficiency with computer programs/systems (MS office, etc.) with demonstration.
ability to learn new systems quickly.
• Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
• Familiar with the drug development process
• Effective interpersonal skills, strong written and oral communication and
presentation skills.
• Solid project management, organizational and time management skills to manage
multiple ongoing projects simultaneously.
• Familiar with global Health Authority regulations/guidances eg., FDA regulations,
ICH and EMA guidelines/directives. Works independently and with minimal supervision.
• Proficiency with computer programs/systems (MS office, etc.) with demonstration.
ability to learn new systems quickly.
• Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
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? https://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: https://talentnetwork.novartis.com/network
Development
REG AFFAIRS GDD
India
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
