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.
Education (minimum / desirable) :
Degree or Ph.D. in Life Sciences, Pharmacy or Medicines
Fluent in English as a business language.
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.