(RA) Regulatory Associate Director (897264-MST)

Location
Basel, Canton of Basel-Stadt (CH)
Salary
Negotiable
Posted
05 Feb 2021
Closes
07 Mar 2021
Ref
897264-MST
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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.

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.

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