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Apply to JobJob ID249784BRPosition TitleSenior Legal CounselJob DescriptionThis position is responsible for providing, within the Pharmaceuticals BU of the Innovative Medicines Division (“IM”) and the corresponding Disease Units in Global Drug Development (“GDD”): (1) regulatory legal support for several global franchises; (2) oversight of enforcement of regulatory exclusivity rights, including regulatory data protection (“RDP”), for selected products and countries; (3) regulatory legal advice for internal stakeholders including Commercial, IP, Medical, Drug Regulatory Affairs (“DRA”) and Public Affairs; and (4) support to the Head of Legal, Global Pharmaceuticals Development, Medical Affairs & Litigation and the Head Litigation Exclusivity.



•Act as the lead regulatory lawyer for the allocated global franchises, providing pro-active, pragmatic and business focussed advice.

•Advise upon securing the optimal regulatory position for the IM portfolio, seeking synergies with the Oncology BU and alignment with the Sandoz Division.

•Provide strategic direction and leadership for enforcement of regulatory exclusivity rights, in collaboration with the IP Function.

•Provide expert legal advice and support (regulatory and contractual) regarding clinical trials/studies, collaborations and consortia, outsourcing of clinical trials to service providers and public institutions, Investigator Initiated Trials (IITs), and for DRA related matters.

•Serve as a center of excellence for regulatory & development law, advising both global and country lawyers and franchise/product teams, in particular with regard to the regulatory frameworks in Europe and US, covering all development phases as well as quality related aspects (GCP and GMP).

•Active involvement in lifecycle management and regulatory legislative activities concerning Novartis Policy and Public Affairs

•Provide training to internal stakeholders on regulatory legal issues and advocate regulatory initiatives.

•Active participation as a member of the Pharmaceuticals Legal Team and GDD Legal Team.



Minimum requirementsLaw degree, preferably bar admission Educational background in science Fluency in English essential; knowledge of at least one other European language preferred

Minimum 5 years’ experience in handling pharmaceutical industry regulatory matters in a business oriented law firm, corporate organisation and/or government agency

. •Ability to analyse complex legal issues

•Strong verbal & written communication skills, together with a high ability to influence and negotiate.

•Proven ability to work well under time pressure & with demanding teams.

•Sound experience in handling a high volume of activity involving multiple, often complex projects simultaneously.

•Professional & culturally sensitive work ethic

•Team-player with collaborative approach.

•Financial/business acumen preferred.DivisionPHARMABusiness UnitGlobal LegalLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaLegal & Intellectual Property & ComplianceJob TypeFull TimeEmployment TypeRegular

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