Senior GPRM/Reg CMC Associate Director (RE2754)

BRINE SA has been placing top specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

Brine SA is looking for a Senior Associate Director for our Client in Basel.

Job Purpose:
Embedded in Regulatory Affairs Innovation and supporting (global and local) cross-functional teams in their collaboration with Digital Partners for digital tools development.

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 participating 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). Experience with these technologies and their usage in a pharma commercial setting is preferred.
– 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 and partner companies to enable them to get beyond the pilot stage of digital-enabled products as they seek to onboard, test and scale digital partnerships
– Develops high quality regulatory strategy for selected global projects. Where partnerships require client global representation at HA meetings, acts as our clients regulatory contact and supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions.
– Where internal processes could benefit from adaptations to suit such digital projects, drive engagement within RA to identify solutions and their implementation by regulatory process owners.
– 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.
– Provides input into the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) for digital-technology supported drugs along with the drug regulatory lead.

Qualifications:
Education: Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph. D, PharmD) preferred.

Languages: Fluency in English as a business language. Additional language is an asset.

Experience:

– Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred). Digital tools are developed to help to support drug development and commercialisation, and so knowledge of drug development and the pharma commercial regulatory landscape is key.

– 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.

– Works effectively in a highly matrixed organization, managing expectations and collaboratively working across all the company’s groups and divisions.

– Exhibits strong leadership skills.

– Strong communication, collaboration skills, writing and problem solving skills

– Ability to work independently

 

 

Work location: Basel
Duration: 1/4/2021 to 31/03/2021
Workload: 80 to 100%
Salary: to be discussed

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA. hrs@brine.ch