Schaftenau, Austria
vor 3 Tg.

Job Description

Manager (m / f / d) Regulatory Affairs , Schaftenau, Austria or Holzkirchen, Germany

8! This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development.

As a Manager Regulatory Affairs (m / f / d) you provide strategic regulatory mentorship and support for our biosimilars during all development phases besides preparing and managing dossier reviews in the markets.

Ideally, you bring regulatory knowledge related to drug development and clinical studies along with a collaborative and patient-focused mind-set.

Your Responsibilities :

Your responsibilities include, but not limited to :

  • Evaluate regulatory requirements and providing regulatory strategies when preparing or managing the timely delivery of high quality documentation required for clinical trials, initial marketing authorization applications and dossier reviews worldwide
  • Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
  • Provide input and collaborate hardworking with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
  • As an active member of the regulatory project (sub) team may act as representative of regulatory functions in the global project team(s)
  • Own the preparation of responses to regulatory relevant queries from various partners and you directly interact with regulatory authorities and / or with regulatory functions in the countries
  • Minimum requirements

    What you’ll bring to the role :

  • University degree in natural sciences, PhD, alternatively several years of regulatory or equivalent
  • 2-3 years’ work experience in biotech regulatory affairs or equivalent
  • Ideally, good understanding of worldwide regulatory requirements regarding drug development (incl. clinical trial submissions, initial marketing authorization applications and dossier reviews)
  • Experience in leading cross-functional sub team in a multi-cultural
  • Proficient in English (oral and written)
  • Desirable requirements :

  • Strong communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams
  • Advanced ability to interpret scientific data and to construct persuasive regulatory documents
  • Contact : Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920

    Why consider Novartis?

    799 million. That’s how many lives our products touched in 2019. 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 offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.

    The base pay is composed of the respective amount according to the Austrian collective agreement (at least € 45,792.46 per year on a full time basis), plus a potential market oriented excess payment.

    We are Novartis. Join us and help us reimagine medicine.

    Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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