Beschreibung
Regulatory Affairs Director- External Partners Support- 12 months contract - home based.We have an exciting opportunity for a senior consultant to join digital transformation division and support regulatory affairs compliance and strategic projects in medicinal products (drug and devices) globally. The purpose of this role is to offer strategic input for external partners, who are in need of support in order to evaluate their innovative products ( devices /drugs, technologies) with regarding to regulatory affairs compliance and their success to introduce their product onto a market.
Responsibilities:
Supports integral part of the RA Innovation group 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,
Provides input into digital tools such as (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 business units and partner companies to enable them to get beyond the pilot stage of digital-enabled products as they seek to onboard,
Develops high quality regulatory strategy for selected global projects.
Where required, takes lead in representing the company at HA meetings, acts as regulatory contact and supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions.
Supports key regulatory submissions, identifies requirements, issues, gaps, and trade-offs affecting optimal and timely registration/clearance., for assigned projects.
Qualifications/ Experience:
Education: Science based BS or MS with requisite experience and demonstrated capability
Strong knowledge of regulatory development, submission and approval processes in major regions for drugs and medical devices, including digital devices (preferred).
Experienced in leading teams in health authority negotiations and making regulatory submissions.
Works effectively in a highly matrixed organization, managing expectations and collaboratively working across groups and divisions.
Exhibits strong leadership skills.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.