Global Program Regulatory Director

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide.

Global Drug Regulatory Affairs leader supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s). Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no DRA sub-team support as appropriate.

Major Accountabilities:

• Provide regulatory leadership to assigned project(s).
• Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
• Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
• Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
• Lead the global submission planning process, including potential Advisory Committees.
• Lead regulatory submission process throughout project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response
• Effective matrix management of regulatory team(s) consisting of GPRM’s and other DRA line functions, providing, to the extent possible, mentorship and opportunities for growth and development.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV
• Prior history with post-marketing/brand optimization strategies and commercial awareness
• Major involvement in a CTD/MAA/NDA submission and approval.
• Proven success in global drug regulatory submissions.
• Proven ability to analyze and interpret efficacy and safety data.
• Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
• Global matrix management people management experience desirable.
• Good management, interpersonal, communication, negotiation and problem solving skills.
• Fluency in English as a business language. Additional language is an asset.
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help
pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we
collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!