Edison-New Brunswick Metro Area, NJ
Responsible for implementing regulatory strategy and managing operational activities for assigned technology/digital projects or teams (as assigned).
Provides input into global regulatory strategy and contributes to Regulatory Functional Plans (RFPs) and Seed Documents, or their equivalents, which outline the global strategic plan for assigned projects.
Develops knowledge in evolving regulatory requirements for digital and other innovative technology programs, and medical device and drug development/maintenance
Understands commercial drivers, including patent and exclusivity matters, patient engagement and advertising and promotional regulations to fulfil business objectives.
Participates in digital support meetings, including SaMD assessment, Block Chain RA Digital Network, and CPO digital/device meetings as assigned.
Supports regions (as assigned) to align on regulatory strategy in order to fulfil business objectives
Supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions.
Supports GPRD-Innovation / DU GPRD on global submissions (including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, dossiers and device clearance planning processes for assigned projects).
Interfaces with external organizations, such as CTTI, PhRMA, EFPIA subcommittees TransCelerate and via initiatives including Innovative Medicines Initiative (IMI) (as assigned).
Supports DU-GPRD-Innovation in developing Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) for combination products and Instructions for Use for digital devices, consistent with development data and commercial objectives of the TPP.
Develops the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with DU RA GPT representative for combination products and Instructions for Use for digital devices, consistent with development data and commercial objectives of the TPP.
Ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes, and keeps records of all major HA interactions in the validated document management system.
Supports digital technologies and digital device evaluations in line with established governance procedures.
Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred).
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
Experience in HA negotiations.
4-6 years involvement in regulatory, drug/biologic development and/or medical device/pharmaceutical combination products spanning activities in Phases I-IV
Strong interpersonal, communication, negotiation, leadership and problem solving skills.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph. D, PharmD) preferred