This position will primarily be responsible for leading the EU CTR (Clinical Trial Regulations) Implementation workstreams across different functions at Regeneron. He/She will understand/implement the EU CTR strategies, priorities/goals and efficiently deliver EU CTR capabilities in alignment with overall Regeneron business priorities.
Additionally, as required, this position will also be responsible for providing Regulatory Intelligence support for proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization,as well as supporting GxP focused intelligence queries from various departments within the organization
Essential Functions required for the job. List both technical and managerial requirements if applicable.
EU CTR Implementation efforts:
Strong project management leadership skills in operating in a cross-functional/matrixed organization and in managing multiple different sub-teams in achieving common project deliverables
Collaborate effectively with EU CTR cross-functional groups to conduct gap assessments, and to enhance, advocate/develop best practices and capabilities to enable robust implementation
Actively engage & lead internal/external EU CTR meetings/discussions across all levels of the organization i.e. project taskforce, sub-teams, senior management and sponsors etc.
Proactively develop solution roadmaps and serve as a point of contact to resolve any escalations/issues
Lead/support business adoption, change management, communication and training with respect to EU CTR roll-out to impacted stakeholders
Communicate effectively with senior leadership; provide data-driven and logical recommnedations to support effective decision-making
Be insight-driven and innovative in her/his conduct. Propose recommendations/ideas/solutions to project management teams, senior management as appropriate.
Lead/supportregulatory intelligence, monitoring and surveillance-related activities:
Provide regulatory intelligence leadership in support of a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.
Collaborate on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders
Strong project management leadership skills in the delivery of regulatory intelligence research services and information
Manage more complex intelligence query requests from internal stakeholders
Functional lead on cross-fucntional organizational level projects or initiatives in supporting of GxP compliance or requirements
Advanced life science degree
Minimum of 6-8 years experience in the biotech/pharmaceutical industry, preferably with Clinical Operations or related background
Expertise in the drug development and clinical development/lifecycle process
In-depth knowledge of GCPs, EU CTR and its associated guidelines is required.
Knowledge of clinical operations/trials management principles is required i.e. study design/conduct/monitor/implementation/close-out, understanding of scientific/trial-related documents, trial execution, external/CRO relationship management, pharmacovigilance etc.
Experienced in understanding and interpreting regulatory guidelines and documents
Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations
Highly organized and able to work independently to meet deliverable on time and on target
Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all level
Attentive to details and focused on quality output
Effective communicator - - both written and oral - in a multi-discipline team environment.
Proficient in the navigation of intelligence database(s)
Prior experience in clinical trial operations
Basic knowledge in the monitoring and sourcing of regulatory requirements information in pharmaceutical industry