Global Therapeutic Area Lead (m/f)

Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 257174BR


Job purpose:

The Global Therapeutic Area Lead Drug Regulatory Affairs leads and supervises assigned regulatory liaisons charged with the development and implementation of regulatory strategy and support of assigned development projects, marketed products and/or major line extensions within the assigned Business Franchise Global Therapeutic Area through development, registration and approval including post approval commitments and life cycle management. The Global Therapeutic Area Lead works in close collaboration with the Regulatory Affairs Global Franchise Head, Region Heads and Sub-region Heads.

Your responsibilities:

Regulatory Strategy
• Has GPRD responsibility for one or more projects
• Ensure high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
• May represent RA in the CSU for the assigned therapeutic area
• Contribute senior level operational and strategic regulatory input into BD&L and oversee Due Diligence evaluations of assigned BD&L projects
• Partnering with regions to align on regulatory strategy in order to fulfill business objectives

HA Interactions, Submissions and Approvals
• Ensure high quality and professional interactions with HAs globally including participation in key formal and informal HA contacts as required.
• Ensure appropriate TA input and consistency of HA interactions and registration activities within and across TAs in line with global strategy

Prescribing Information
• Ensure high quality, consistent labels across therapeutic areas and ensure timely implementation of CDS changes

Regional Excellence and Compliance
• Ensure compliance with global regulatory requirements and adherence to internal policies and processes and coordinate compliance activities at a global level
• Oversee and provide support as needed for non-project related regional excellence activities
• May be member of site-based leadership Teams

• Supervise and lead GPRDs, GPRMs or GMRMs assigned to the Global Therapeutic Area Team including performance management, in collaboration with the global line functions, and the DRA Global Franchise Head and the Global Program Head
• Ensure high quality global regulatory strategies within the Global Therapeutic Area Team
• Advise GPRDs, GPRMs and GMRMs to drive development, provide strategic regulatory input into development plans and provide regulatory support to maximize the probability of success and support well-informed business decisions
• Provide GPRDs, GPRMs and GMRMs with opportunities for growth and development
• Optimize staffing of projects within Global Therapeutic Area Team in cooperation with the DRA Franchise Head
• Ensure synergy where appropriate across the group of projects at a global level, regardless of location
• Ensure timely, clear communications on project/TA regulatory status/issues/risks with teams, DRA line management, and key stakeholders internally, and with Health Authorities, as appropriate
• Serve as role model and embrace NVS Values and Behaviors
• Commitment to drive efficiency while maintaining quality

Research & Development



• Science based Bachelor of Science or Master of Science with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) is preferred
• Minimum 8–10 years development experience in pharmaceutical industry and minimum 5 years relevant regulatory experience which includes the following: GPRD or equivalent experience on multiple/complex projects, involvement in MAA and NDA submission(s) and approval(s) with proven success
• Fluency in English as a business language. Additional language is an asset

Why consider Novartis?

927 million. That’s how many lives our products touched in 2017. 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.

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.
We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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