(RA) Regulatory Associate Director (897264-MST)
- Experience Level
- Senior Management
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for 2 Senior GPRM/Regulatory Associate Directors to be based in Basel for a 12-month contract position, with high chances of extension.
- Works as an integral part of the RA Innovation group (embedded) and ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes;
- Provides regulatory leadership on digital tools development supporting global and local commercial/development teams in alignment with company approach and engaging with external partners. Digital tools may involve the use of SaMD apps, non-medical device software applications, website functionalities, as well as targeted hardware devices incorporating digital functionalities of interest to global and/or local teams e.g. patient support, disease awareness tools, sensors (medical devices and/or consumer grade);
- Acts as global regulatory contact with local teams and connects with other internal experts to provide coordinated, cross-functional guidance and support to (Global/Local) business units;
- Develops high quality regulatory strategy for selected global projects;
- Supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions;
- Supports key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, drug dossiers and device clearance planning processes. Identifies requirements, issues, gaps, and trade-offs affecting optimal and timely registration/clearance., for assigned projects.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- BS or MS in Science. Advanced degree (MD, Ph. D, PharmD) preferred;
- Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred);
- Experienced in leading teams in health authority negotiations and regulatory submissions, and in driving good regulatory practice for in-market pharmaceuticals, having key awareness of the variety of regulatory diversity around the globe for promotion and marketing of launched medicinal products and associated medical devices;
- Exhibits strong leadership skills;
- Fluency in English, additional language is an asset.
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