Brief Description:

The primary responsibility of this role is to lead the creation of regulatory documents, processes and the development of regulatory strategy to achieve regulatory approvals and clearances worldwide expediently and consistently within all studies, interventional and non-interventional.

Specific Job Duties:

• Write and submit regulatory and/or technical documents with minimal review from senior staff for assigned projects.
• Act as Regulatory Lead for complex projects / programs or for mentoring junior staff.
• Provide regulatory expertise to clinical project teams and clients (e.g., CTA applications, importation of clinical trial material, reporting of adverse events).
• May be responsible for the registration and/or publication of clinical trial / study related information on clinical trial databases.
• Develop the regulatory application strategy, including the submission requirements, associated costs and time schedules necessary to achieve global project approvals as required by the project plan in a timely and cost-effective manner.
• May develop and/or review regulatory SOPs and other guidance required for delivering regulatory operations.
• Responsible for process implementation and ensure process compliance within the regulatory Operations team.
• Develop and maintain internal regulatory intelligence by proactively investigating, analyzing and capitalizing key regulatory regulations, legislations and guidance at local, regional and global level.
• Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of metrics to regulatory management or designee.
• Provide robust regulatory and/or technical information to support key sponsor regulatory project milestones (e.g., ensure that all country and local regulatory requirements are addressed for the clinical research program and for marketed products).
• Serve as worldwide technical expert, on relevant regulatory issues potentially impacting the study. Defend UBC and/or Sponsors’ approach at local, regional or international forums where science- based harmonized approaches may be influenced and promoted.
• Propose, in line with the business timelines, the 1-5 year regulatory studies and activities budget, specifying quality standards to be met, and making best use of UBC’s resources. Contribute to the creation and updating of robust Project Plans and whenever required, provide feedback to such teams on achievements and bottlenecks.
• Develop professional relationships with MoH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
• Provide country specific regulatory expertise to customers and clinical operations teams.
• May participate in bid defence meetings to present regulatory deliverables and provide strategic advice, at the discretion of senior staff.
• May supervise, train and mentor junior regulatory affairs team members, including providing feedback on the quality of technical documents.

• Other duties as assigned by EU Director Clinical Regulatory Operations /designee or UBC Management.

• Master degree in life science-related discipline or professional equivalent plus 3-5 years’ regulatory experience pertinent to clinical trials, non-interventional studies and/or registries (or a combination of education, training and experience).
• Demonstrates comprehensive regulatory expertise including preparation and submission of CTAs, the applications for import licenses, and any reporting procedures, e.g, SAE reporting obligations and procedures.
• Recognized expertise in regulatory affairs including thorough knowledge of international guidelines and regulations applicable to clinical research (e.g. GCP, GVP, GEP/GPP, EUCTR…).
• Fluent in English.
• Very strong organization, planning and budget tracking abilities to handle potentially conflicting multiple portfolio projects.
• Strong leadership abilities to unite diverse groups to a common task and strategy.
• Excellent verbal and written communication skills to collaborate with and discuss technical information and regulatory requirements with project teams and governmental agencies.
• Expertise with information management technology (e.g., archiving databases, document editing software, statistical manipulation of data).
• Demonstrated networking ability and negotiation skills to work within sponsor and government systems building expert networks and applying them to address business needs.
• Ability to work effectively with lengthy project review periods.
• Flexibility, adaptability, diplomacy, and ability to overcome complexity.
• Respect for and understanding of cultural diversity
• Ability to successfully work in a ‘virtual’ team environment.
• Ability to work with all levels of management.
• Ability to travel internationally and domestically.
• General computer proficiency including Microsoft Word, Excel, Access, Internet, and experience with document tracking tools.
• 10% travel availability

#LI-AP1

#LI-Remote