Head RA MOW Strategic Ops & Compliance

Oct 15, 2021

Job Description

33 major submissions, 24 major approvals, 5 new molecular entities! That was 2019. Help us continue reimagining medicine by reimagining your career at Novartis. Our Global Regulatory Affairs (RA) group features a wide array of accomplished professionals and recent hires for an ideal blend of experience, talent, and diversity. In addition, you could be a part of this cutting-edge team. Consider the possibilities via a career at one of the top-tier pharmaceutical companies. Our focus includes pursuing an extraordinary pipeline of promising medicines, exploring data and digital innovations, providing access to patients around the world, and helping sustain the environment for decades to come. Flexible, family friendly work arrangements ensure you have time to balance everything that’s important to you while contributing to an organization that’s dedicated to enhancing patients’ lives, including pursuing potential treatments for intriguing rare disease conditions with unmet needs. Because we are OneNovartis, OneRA, and one world at large. Read on for details on how you can take your career in an exciting direction and become part of our global community.

Your responsibilities will include, but are not limited to:

- Drive development of working models to support enhanced compliance status for the Novartis Innovative Medicine portfolio across the region.

- Drive approaches to improve regional RA operational and functional excellence supporting global and regional commercial priorities and ensuring regulatory compliance is maintained for the Novartis Innovative Medicine portfolio.

- Lead strategic planning and regulatory actions to achieve timely, competitive registration across select MOW countries for the Novartis Innovative Medicine portfolio.

- Ensure sophisticated regulatory input is contextualized and communicated to cross-functional groups and global teams supporting leverage of innovative approaches to accelerate registrations and optimize product life cycle maintenance where possible.

- Drive development of working models to support enhanced regulatory compliance status for the Novartis Innovative Medicine portfolio across the region

- Provides strategic and operational regulatory direction, Subject Matter Expertise and act as project manager for assigned projects and initiatives

- Leads all aspects of the planning and execution of manufacturing site registrations and local HA GMP inspections cross-regionally (e.g. MOW, LATAM). ‘Translate’ sophisticated issues into tangible actions and strategic considerations for countries and manufacturing sites.

- Develops training plan for RA MOW to ensure capability building of RA MOW countries and improving cross-regional knowledge and understanding to global RA organization (e.g. ‘Around the World’ sessions)

- Ensure regulatory intelligence is translated into tangible regulatory strategy for Novartis Innovative Medicine portfolio in collaboration with the country RA teams and global RA policy roles.

- Drive operational and functional excellence of RA Country heads/team in collaboration with Region and Sub-region RA heads, including the development of enhanced working models for RA business efficiency and personal engagement at region/sub-region level

- Identify and use opportunities for cross-country and cross-regional collaboration, shared findings and harmonies with sub-region heads

- Lead strategic planning and actions to achieve timely, competitive registrations for the Novartis Innovative Medicine portfolio (across select countries) in collaboration with sub-region heads to ensure the earliest launches in line with commercial priorities

Minimum Requirements

What you’ll bring to the role:

- Proven experience in Regulatory Affairs in the Pharmaceutical and/or Medical Device Industry

- Deep understanding of GxP Regulations and global Regulatory Guidelines

- Good understanding of regulatory environment in MOW region and regional regulatory requirements

- Excellent communication skills

- Excellent communication, presentation, negotiation and problem solving skills.

- Good knowledge of the regulatory processes for drug development and regulatory compliance of marketed products

- Ability to work globally to initiate and co-ordinate the work of associates at all levels

- Ability to communicate sophisticated concepts and ideas verbally and in writing

- Strong analytical skills and critical thinking

- Ability to work optimal cross-functionally, in a team environment across cultures

- Considerable organization awareness (e.g. interrelation-ship of departments, business priorities) and strong cultural awareness

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
Global Drug Development
Research & Development
Full Time
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Head RA MOW Strategic Ops & Compliance

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