Senior Manager Regulatory Affairs Digital Innovation
Posted on Feb 14, 2021 by Michael Bailey Associates - UK Contracts
Senior Regulatory Affairs Manager- Digital innovation- 12 months contract - home based
We have an exciting opportunity for a senior regulatory affairs consultant with broad experience in development and post marketing stage for pharmaceutical products and medical devices/combination devices.
Supports RA Innovation group and ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes
Provides regulatory leadership on digital endpoint development supporting drug development teams in alignment with company approach. (Digital endpoints may involve the use of SaMD, ePRO, eCOA, and sensors (medical devices and/or consumer grade), - experience with these technologies is preferred.
Develops high quality regulatory strategy and health authority engagement plans.
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.
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.
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.