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      Novartis AG

      25.11.2022

      Senior Global Program Regulatory Manager

      • 4051Basel
      • Festanstellung 100%

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      Novartis AG

      Novartis bietet innovative medizinische Lösungen an, um damit auf die sich verändernden Bedürfnisse von Patienten und Gesellschaften einzugehen. Novartis, mit Hauptsitz in Basel (Schweiz), verfügt über ein diversifiziertes Portfolio, um diese Bedürfnisse so gut wie möglich zu erfüllen: mit innovativen Arzneimitteln, Produkten für die Augenheilkunde und kostengünstigen generischen Medikamenten. Novartis ist das einzige Unternehmen mit weltweit führenden Positionen in diesen Bereichen.
      Novartis bietet innovative medizinische Lösungen an, um damit auf die sich verändernden Bedürfnisse von Patienten und Gesellschaften einzugehen. Novartis, mit Hauptsitz in Basel (Schweiz), verfügt über ein diversifiziertes Portfolio, um diese Bedürfnisse so gut wie möglich zu erfüllen: mit innovativen Arzneimitteln, Produkten für die Augenheilkunde und kostengünstigen generischen Medikamenten. Novartis ist das einzige Unternehmen mit weltweit führenden Positionen in diesen Bereichen.

      Senior Global Program Regulatory Manager

      Arbeitsort: 4051 Basel

      mehr Infos zu diesem Job
      Job ID 354528BR Oct 28, 2022 Switzerland

      Job Description

      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.

      The Global Senior Manager Regulatory Affairs Sandoz Biopharmaceuticals supports one or more biosimilar/biotech projects, and compiles and prepares high quality regulatory documentation for complex global regulatory submissions worldwide in a timely manner. The Sr Mgr RA is responsible for executing and implementing the regulatory strategy besides providing regulatory and strategic support of assigned biosimilar/biotech project(s) and tasks through development, registration and approval/post approval. The Snr RA Mgr works independently under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs global program team (GPT) representative and/or GTAL for programs. In certain cases, the Snr RA Mgr may be the GPT

      Major Accountabilities:
      • Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
      • Provides input into global regulatory strategy and contributes to Regulatory Strategy Plans and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
      • Partners with regions to align on regulatory strategy in order to fulfil business objectives.
      • Implements strategy across assigned regions.
      • Works with Regulatory Affairs Sandoz Biopharmaceuticals (RASB) GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy.
      • Works with RASB GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.
      • Develops and implements regulatory readiness with other line functions, Country Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RASB GPT representative and/or GTAL.
      • Represents RASB on or leads sub-teams as required.

      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

      • Mininum 5 years work experience in biotech Regulatory Affairs (proven high learning curve within organization or industry experience gained in relevant fields could potentially being considered)
      • Excellent data processing skills (incl. MS Office)
      • Strong knowledge of development processes and of basic science
      • Strong ability to interpret scientific and commercial information
      • Strong analytical problem solving skills
      • Strong strategic and conceptual thinking
      • Strong ability to construct persuasive scientific/regulatory documents
      • Good understanding of regulatory requirements for filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance
      • Strong ability to work in a complex and international setting
      • An advanced degree in life sciences/healthcare (PharmD/PhD) or relevant industry experience
      • Fluent English required (oral and written)

      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!Division SANDOZ Business Unit BioPharma SZ Location Switzerland Site Basel Company / Legal Entity Sandoz AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account