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Business Integration Manager, Regulatory Operations

Company: Novartis Pharmaceuticals
Location: East Hanover
Posted on: June 12, 2021

Job Description:

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 GDD Regulatory Affairs Operations responsible for managing external data integration and extraction processes in support of the broader organization goals and objectives related to Mergers, Acquisitions and Divestments.

Your Responsibilities include but are not limited to:

  • Manage internal partnership with RA, RA Ops and key cross-functional teams (BD&L, Alliance Management, Legal, IT etc.) and assist Head RA Ops, M&A to help design and execute a robust and scalable cross functional M&A strategic program/framework
  • Ensure compliance to Security and Compliance, SOPs, WPs and all related internal processes and procedures
  • Collaborate closely with Head Ops, M&A, Ops LT and respective teams to help drive RA Operations project management excellence related to M&A and Divestment activities
  • Support Head RA Ops, M&A in planning (including prioritization), management (including risks, project status reports, timelines) and coordination of required activities to transform our business as relates to RA
  • Assist in developing and implementing a communication/ change management plan and Business Continuity Plan
  • Partner with cross functional groups across the organization to create and maintain business driven data migration and transition plans
  • Coordinate business related regulatory activities with IT operational support and 3rd parties involved in divestment initiatives
  • Support operational tasks related to transfer of regulatory data within the systems managed by RA Operations as needed

[#video#https://youtu.be/Mo1vwtVPVA0{#400,300#}#/video#]

What you'll bring to the role:

  • BS or MS degree in a relevant subject area with at least 5+years of professional work experience.
  • 5 years Regulatory and/or relevant IT experience in Pharma preferred
  • Familiar with drug development process, worldwide regulatory practices, electronic submission guidelines and requirements as well as document management processes and tools
  • Excellent Project management skills to help plan and lead M&A activities in a fast-paced Regulatory environment
  • Some experience with regulatory systems and related software/tools preferred
  • Knowledge of industry leading external data integration tools and new technologies supporting data integration is preferred
  • Ability to effectively collaborate and partner with internal/external vendors, stakeholders and colleagues in a multi-cultural, global team environment
  • Proactive, accountable for deliverables and able to adjust to constant change and the challenges incurred

Why consider Novartis?

799 million. That's how many lives our products touched in 2019. 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!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network

Keywords: Novartis Pharmaceuticals, New York , Business Integration Manager, Regulatory Operations, Other , East Hanover, New York

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