(RA) Regulatory Associate Director (897264-MST)

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.

Main Responsibilities:

• 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.