Full-Time Manager, Start-up and Regulatory Affairs

• Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of SSU/regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Develop strategy and manage set up activities (SSU RA Management Plan, procedures and core documents) ensuring compliance and consistency with department standards. Support team members in preparing project strategy, identifying issue and providing resolution.
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
• Ensure preparation, collection, review of regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
• Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
• Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
• Provide expert advice to Clients addressing complex SSU/regulatory queries ensuring consistent and high-quality advice across all regions.
• Ensure that all communications with Regulatory Authorities and Ethics Committees/IRBs are carefully tailored to the specific requirements and tale place only when essential guidance cannot be obtained through other available resources.
• Reviews the project SSU budget and scope of work with the project PM against project milestones and budget to ensure project profitability. Pro-actively discusses corrective measures with the project PM where necessary to keep project in line with budget and gross profit expectations.
• Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.
• Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan).

What is the last date for applying to the job?

Which countries are accepted for this remote job?