Regulatory CMC Senior Manager
Schaftenau, Austria
vor 1 Std.

Job Description

Regulatory CMC Senior Manager (m / f) - Biosimilars, Schaftenau, Austria

8! This is the number of biosimilars for which Sandoz, the global leader in biosimilars, has already received marketing authorization approval worldwide und thus has increased access to life-saving medicines.

Multiple additional biosimilars are in development. As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for biopharmaceutical products covering development and post-approval activities.

You bring a foundation of regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mind-set.

Your Responsibilities :

Your responsibilities include, but not limited to :

  • Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance
  • Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects / products
  • Identify the required documentation and any content, quality and / or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Author and / or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements

  • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders as well as represent department in cross-functional project teams.
  • Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions
  • Initiate and lead Health Authority interactions and negotiations
  • Minimum requirements

    What you’ll bring to the role :

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent with oral and written fluency in English
  • Ideally, at least 5 years’ experience in regulatory and / or in the pharmaceutical industry with a working knowledge in regulatory submissions
  • Knowledge of product development and life cycle desirable, including a working knowledge of chemistry / biotechnology, analytics, and / or pharmaceutical technology and the ability to critically evaluate data from these disciplines
  • Ability to manage complex CMC regulatory challenges and requirements while leading / working in interdisciplinary global teams
  • Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
  • Desirable requirements :

  • Clear communication with a collaborative and patient-focused mind-set
  • Computer / IT systems literacy
  • Contact : Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920

    Why consider Novartis?

    750 million. That’s how many lives our products touch. 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 a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 50,374.

    38 per year on a full time basis).

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

    Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

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