Job ID 321665BR Position Title Global Regulatory Submission Publishing Apply to Job
Job Description
Global Regulatory Submission Publisher Associate
26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely-knit team.
A position in Global Drug Development Regulatory Affairs Operations responsible for electronically preparing, publishing and dispatch of HA compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
Your responsibilities will include:
• Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS) in adherence to assigned timelines and in compliance with worldwide HA requirements
• Liaise/collaborate with cross-functional team members and document authors from various line units to achieve timely dispatch of high quality submissions
• 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
• Contribute to process efficiencies, process documentation and knowledge transfer efforts within the RA team
Minimum requirements
What you’ll bring to the role:
• BS in life sciences or a relevant discipline
• 3-5 years submission publishing experience in Pharma or related industry
• Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria
• Effective interpersonal skills, strong written and oral communication and presentation skills
• Strong organizational and time management skills in order to navigate competing and complex priorities
• Results driven and action oriented
• Demonstrated negotiation skills and a positive attitude
Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis! Division Global Drug Development Business Unit REG AFFAIRS GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
