Regulatory Affairs Manager

vor 3 Wochen

Schaftenau, Österreich Novartis Vollzeit
Job Description

As a key member of our Development Team, you will play a critical role in shaping our company's purpose: to reimagine medicine to improve and extend people's lives.

We are optimizing and strengthening our processes and ways of working to bring our medicines to patients even faster. We are seeking talented individuals like you to join us and help give people with disease and their families a brighter future to look forward to.

Key Responsibilities:
  • Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Biologics and Small Molecules projects/products.
  • 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.
  • Represent the department in cross-functional project teams.
  • Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
  • Initiate and lead Health Authority interactions and negotiations.
Requirements:
  • Education: Minimum Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
  • At least 2 years' experience in regulatory CMC experience and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
  • Demonstrated working knowledge of chemistry/biotechnology, analytics, or pharmaceutical technology.
  • Knowledge/experience of regulations, guidelines, and product life cycle maintenance desirable.
  • Ability to critically evaluate data from a broad range of scientific disciplines.
About Novartis:

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

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