Global Program Regulatory Director (d/f/m), Kundl, Tyrol, Austria
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Regulatory Strategy:
-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.
• HA Interactions:
-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.
• Submissions and Approvals:
-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) (indirect reports) consisting of GPRM's and other DRA line functions, providing, to the extent possible, mentorship and opportunities for growth and development.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
• Innovation in regulatory strategy.
• Prior history with post-marketing/brand optimization strategies and commercial awareness
• Major involvement in a CTD/MAA/NDA submission and approval.
• Leadership role in HA negotiations in multiple regions.
• Proven success in global drug regulatory submissions.
• Proven ability to analyze and interpret efficacy and safety data.
• Regulatory operational expertise.
• Fluency in English as a business language. Additional language is an asset.
• 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.
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 80,433.64/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competenciesWe are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool