Specialist, Regulatory & Site Activation

Specialist, Regulatory & Site Activation

What you will do

Subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation, and maintenance for awarded projects. Responsible for planning, initiating, and tracking documents required for regulatory submissions, essential document collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks, and actions related to any start-up activities and maintenance when applicable.

Tasks may include but are not to be limited to:

• Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
• Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
• Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements
• Review and provide advice on country timelines for the assigned studies
• Effectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissions
• Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines and relevant study specific plans.
• Track study-specific regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the RAM
• Proactively identify risks and generate mitigation strategies at country/site level
• Advise the RAM/project team about appropriate country regulatory strategies
• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
• Provide timely and relevant updates of changing regulatory requirements, support on interpretation of new regulations, and maintain regulatory intelligence database for the assigned country
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations
• Where required provide local QC of submission dossiers prior to dispatch
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.