Regulatory Policy Director
Sandoz Canada
Basel, Switzerland
vor 4 Tg.

Job Description

Optimizing the use of new regulatory requirements, intelligence and policy to define and manage the strategic direction for quality global development to achieve commercial objectives.

  • Act as project Leader for RA in business critical projects encompassing cross functional or cross divisional activities
  • Represent Novartis on external committees e.g. trade associations such as EFPIA, EuropaBio and their ad-hoc working groups, and speak at external conferences in area of expertise.
  • Ensure Novartis priorities are included and addressed.

  • Represent RA in assigned IMI projects and deliver appropriate expert input.
  • Provide context and direction for interaction with the European Medicines Agency (EMA) by leveraging familiarity with, and knowledge of, the regulatory environment and culture.
  • Monitor and search relevant laws, guidelines and other pieces of regulatory information (draft / in force) from Health Authority webpages and public databases, public conferences, workshops as
  • well as via exchange of information at meetings with working groups of trade organisations, learning from Scientific Advice for our products, etc.

  • Contribute to internal knowledge management systems (databases, queries, benchmarking) and produce analyses on demand
  • Identify and escalate key information as appropriate within RA, Development and COs.
  • Evaluate impact and anticipate implication of important emerging regulatory requirements and political environment on Novartis projects and business.
  • Prepare and coordinate Novartis feedback on draft EU legislation / guidance, successfully shaping and influencing them via interactions with Authorities and Pharmaceutical Trade Organizations.
  • Communicate new and emerging regulatory requirements by providing training sessions to
  • RA colleagues, COs or cross functionally and via written communication, such as newsletters, information e-mails etc.

  • Provide strategic advice on drug development projects and registration in Europe to RA
  • colleagues and GPTs.

  • Support / contribute to the development of EU public policies and / or topic viewpoints
  • Manage / coach group members (e.g. interns, post-graduates) and contribute to the development of the team.
  • Oversees activities relating to the management of Novartis Europharm Ltd
  • Act as deputy to Head of group.
  • Minimum requirements

    Education (minimum / desirable) :

  • Degree or Ph.D. in Life Sciences, Pharmacy or Medicines
  • Languages :

  • Fluent in English as a business language.
  • Experience :

  • At least 7 -10 years’ experience in regulatory activities in drug development including involvement in MAA submission and approval as a team member
  • Lead role in a RA specific or cross functional ad hoc special project and due diligence activities for licensing activities
  • Experience in / as a representative in a pharmaceutical industry trade association can be useful.
  • Experience as RA Manager in a CO or Health Authority could be useful as well
  • Regulatory Science - Up to date expert knowledge of European regulatory requirements for drug development, registration as well as for maintenance or life cycle management.
  • Regulatory Communication and Negotiation - Interprets and communicates new or evolving changes in regulatory requirements and environmental change to a broad internal audience and provides strategic input to Novartis cross-
  • functional teams to address developmental and regulatory issues.

  • Drug Development - Excellent understanding of drug development processes and the impact of regulatory science on drug development, sound scientific knowledge.
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