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Job Details
Novartis
Global Regulatory Submission Publishing Associate
Job Description
1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects.
We also focused on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.
An individual contributor position in Global Drug Development Regulatory Affairs Operations accountable for all publishing, verification, dispatch and coordination of HA compliant, worldwide regulatory submissions in support of NVS global product portfolios.
Your Responsibilities include, but are not limited to:
• Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
• Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World).
• Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, Europe and India) and actively functions in a global capacity.
• Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and
Quality functions) to achieve timely dispatch of high-quality submissions.
• Comply with and actively apply internal work practices and guidelines.
• Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
• Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
• Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
This position can be filled at either the East Hanover, NJ or Bannockburn, IL sites.
We also focused on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.
An individual contributor position in Global Drug Development Regulatory Affairs Operations accountable for all publishing, verification, dispatch and coordination of HA compliant, worldwide regulatory submissions in support of NVS global product portfolios.
Your Responsibilities include, but are not limited to:
• Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
• Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World).
• Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, Europe and India) and actively functions in a global capacity.
• Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and
Quality functions) to achieve timely dispatch of high-quality submissions.
• Comply with and actively apply internal work practices and guidelines.
• Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
• Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
• Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
This position can be filled at either the East Hanover, NJ or Bannockburn, IL sites.