14 days ago on sjobs.brassring.com

Global Program Regulatory Director

Novartis Pharma Schweiz AG

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Global Program Regulatory Director

Job ID197972BRPosition TitleGlobal Program Regulatory DirectorDivisionPHARMABusiness UnitGlobal Develop NPHCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularJob DescriptionThe Global Program Regulatory Affairs Director will support Global Program Team(s) (GPTs) and function independently with minimal supervision as a core member of the Global Program Team to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s). Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibily.

Major Accountabilities:
- Provide regulatory leadership to assigned project(s).
- Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
- Ensure that Regional/Country Pharma Organization (CPO) input is sought and incorporated into global regulatory strategy
- Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
- Responsible for development and implementation of the Regulatory Seed Document/Regulatory Functional Plan.
- Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally.
- Partner with regions to align on regulatory strategy in order to fullfill business objectives.
- Obtain timely consultation with Drug Regulatory Affairs (DRA) line management and Novartis advisory boards on regulatory strategy.
- Lead interactions with regulatory consultants/advisors for strategic input and challenge.
- Represent DRA on the GPTs and communicates key program information to regulatory team members and DRA management.
- Provide strategic input to GPT and DRA team on key Health Authorities (HA) documents, obtaining appropriate line endorsement as appropriate.
- Provide strategic input, review and approve clinical study protocols and protocol amendments
- Lead DRA activities regarding Novartis safety risk communications for the assigned projects.
- Provide strategic regulatory input into BD&L Due Diligence evaluations as required.
Minimum requirementsEducation:
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.


Professional Experience:
- Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas: -Innovation in regulatory strategy.
- Prior history with post-marketing/brand optimization strategies and commercial awareness
- Major involvement in a CTD/MAA/NDA submission and approval.
- Leadership role in HA negotiations in multiple regions.
- Proven success in global drug regulatory submissions.
- Proven ability to analyze and interpret efficacy and safety data.
- Regulatory operational expertise.
- Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
- Global matrix management people management experience desirable.
- Good management, interpersonal, communication, negotiation and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working crossfunctionally.