Regulatory Affairs Manager
• Responsible for performance (quality, profitability, utilisation) of direct reports, ensuring consistent regulatory support, in accordance with Global Regulatory Affairs business plans. Ensures objectives of individual staff and teams are in line with overall Regulatory Affairs objectives by facilitating regular communications.
• In depth experience in creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
• Strong domain knowledge in both report level and submission level publishing activities.
• Good understanding of overall project management activities within publishing or submissions.
• Participate in the selection and on-boarding process for new Regulatory publishing staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems access and training to complete job responsibilities.
• May act as a Subject Matter Expert (SME) or Project Manager on any type of publishing or submission publishing project and may provide strategic regulatory or technical consultancy.
• May prepare a single service regulatory publishing or clinical document publishing proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed.
• Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to IQVIA and customers, thereby consistently receiving positive customer feedback.
• Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.
• Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies, communicating this in a positive manner to staff.
• Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guide. “Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications”.
• Planning, preparing, tracking of regulatory publishing and submission projects. Thereby keeping close track of monitoring the revenue, budget for publishing CoE.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA and ICH.
• May represent on project team meetings, driving timelines and deliverables related to submission documents. Present to Customers on periodic status of the projects.
• Strong Technical knowledge of electronic publishing systems and software (RIM Smart, Insight, eCTDXpress, Extedo, Lorenz, Toolbox, Document management system). Will be contributing for the eCTD tool development activities.
• Self-starter with superior time management skills, and ability to work independently or in teams.
• May design training materials and deliver training externally and internally.
• Contribute in keeping the SOP, Work Instruction and Checklists update regularly, as needed.
• May represent region or site on a regulatory, technical or cross-functional Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.
Job posted: 2021-04-28