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Job ID 333277BR Position Title Head of Regulatory Affairs Lifecycle Management Apply to Job
Sandoz is a premier Generics company with a broad portfolio of over 1000 high quality generic medicines, >30,000 Marketing Authorizations worldwide, serving over 500 million patients globally.
A senior leadership position has become open in the Sandoz Global Regulatory Affairs (GRA) leadership team. The Global Head of Lifecycle Management & Portfolio Expansion is a key leadership position responsible for directing a global function of 180 FTE’s, responsible for lifecycle management and geographic expansion of the extensive Sandoz small molecule portfolio across 130 countries. This requires close alignment and collaboration with the Sandoz manufacturing and supply organisation to oversee manufacturing optimisation and compliance related regulatory filings and also with commercial and regional portfolio functions to support the geographic expansion of Sandoz established products globally.
Accountable for leading the Sandoz regulatory function responsible for product maintenance and portfolio expansion globally across US, EU, Japan and International Markets for the small molecules business.
Reporting to the Global Head of Regulatory Affairs and as member of the Global Regulatory Leadership Team, will help drive the transformation of the global regulatory organization to become a high performing and strategic asset for Sandoz.
Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?
A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
Your responsibilities include, but not limited to:
• Leads the regulatory lifecycle management and portfolio expansion function (total headcount approx. 180 across, 5 global locations)
• Directs the function to efficiently implement post approval variations to implement manufacturing changes, process improvement and compliance initiatives
• Directs the function to provide timely risk assessment and dossier provision for geographic and portfolio expansion of established products worldwide
• Drives operational excellence and transformation initiatives to optimise department performance
• Represents Sandoz in appropriate industry forums, engages in external lobbying activities and maintains effective relationships with key regulatory agencies worldwide.
• As a key member of the Global Regulatory Affairs leadership team actively contribute to the overall strategic direction of the GRA function
EEO StatementNovartis is 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:
• Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biology) or equivalent.
• Desirable: Advanced Degree in Science.
• Fluent English required (oral and written); good skills in local language of site desired (oral) are an advantage.
• Experienced global regulatory leader with at least 15 years regulatory experience in roles of increasing accountability, ideally in the generic field. Experience from other pharma areas is a plus.
• Strong knowledge and interest in the evolving regulatory landscape of ICH and non-ICH countries.
• Professional Competencies:
o Advanced leadership skills; sets clear vision and directions and aligns teams. Motivates and develops to reach out for excellent performance. Inspires to pro-activity and innovation.
o Comprehensive DRA understanding, excellent knowledge on relevant regulatory guidelines and very good understanding of authority expectations worldwide
o Good understanding of Manufacturing and QA fundamentals. Key interface to these functions.
o Broad scientific and strategic background.
o Good understanding of generic market structures.
o Solid knowhow of project management techniques. Knowhow in quality assurance and pharmaceutical technology.
o Proven track record in organisational transformation and change managementy
o Proven track record of creativity, problem solving and productivity.
o Excellent skills in presentation and scientific / technical writing, advanced communication and negotiation skills
o Demonstrated successful experience working in interdisciplinary teams in a complex matrix environment and dealing with continuous change and occasionally conflicting priorities.
o Experienced in operating effectively at senior executive level
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! Division SANDOZ Business Unit Product Dev SZ Location Switzerland Site Basel Company/Legal Entity Sandoz AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
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