Job Description
Key Skills: Regulatory Startup Manager . Lead CRA, Regulatory, Study StartUp
Bachelors level degree in life sciences, pharmacy, nursing or RN, or equivalent clinical research experience, higher degree and/or regulatory professional qualification desirable
Excellent regulatory knowledge, with at least 3 years specific experience in managing the regulatory start up process with at least 2 years specific to start up for global clinical trials
Line management experience is preferred
Ability to successfully prioritize and work on multiple tasks
Strong leadership and problem solving skills
Ability to train, manage and assist more junior staff members
Ability to learn and apply SOPs and relevant regulations pertaining to clinical studies
Ability to establish effective relationships with sponsors, as well as team members
Excellent attention to detail
Effective written communication skills
Job Description
Work with Sponsor and/or Project Management before study begins to create project-specific regulatory strategy and tactical plan. This plan may include a regulatory start up plan, development of timelines for submissions, the investigational product release procedures, and will define any sponsor/project team essential documents required for completion of the submissions to CA/EC/IRB.
Develop template regulatory document package for CA and EC/IRB. In some cases, prepare and send essential regulatory document packages to approved investigative sites, CA and/or EC/IRB
Manage, prepare, track, QC and/or submit CA packages and Central or local EC/IRB submissions, with the assistance of the start up team as required
Provide guidance and leadership to start up team and site personnel on completing necessary regulatory documentation
Manage, prepare, track, QC and/or submit submissions of Amendments, IB updates, etc., to the CA/EC/IRB as appropriate or with assistance of start up team
Monitor and manage the work of the start up team members assigned by the Regulatory Affairs, Contracts, and Clinical Monitoring departments
Provide PM and Sponsor with regulatory and contract status updates, as defined by the communication plan
Foster constructive and professional working relationships with all study-related contacts
Responsible for mentoring junior staff members in the department
Organise and deliver training sessions for project teams and other members of the Regulatory Affairs Department, as appropriate
Work with the management team to design, implement, and improve procedures to ensure the smooth start up of global projects.
Keep up-to-date with and, as far as possible, anticipate new or changing regulatory requirements in relevant territories. With the other members of the team, ensuring the WIKI regulatory intelligence site is maintained with pertinent source document intelligence and additional reference information in an up-to-date, comprehensive and user-friendly system.
Ensure that regulatory approvals remain in compliance with their authorisations and with current regulatory requirements. This includes scrutinising and making recommendations on all relevant documents e.g. labelling, patient information leaflets and data sheets to ensure conformance with appropriate current requirements.
Ensure that the head of Regulatory Affairs is kept informed of the status of the work programme, and that other groups (e.g. CRAs, Medical & Scientific Affairs) are advised accordingly.
Work within the SOP/QP system.
Perform other related duties as assigned or requested by the Regulatory Affairs Manager or Director of Regulatory Affairs.
Support Business Development by preparing and reviewing regulatory sections of proposals and feasibility reports, reviewing regulatory and start up budgets, providing strategic regulatory advice, and attending and presenting at bid defense meetings
