Requirements: English
Company: Sanofi EU
Region: Budapest ,
Location: BudapestJob type: Permanent, Full-timeHybrid working according to local policy
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Join our Global Regulatory Affairs organisation as
Country Clinical Trial Application (CTA) Regulatory Manager Team Lead
and you will lead the Hungarian CTA group (Country CTA regulatory managers, CTA coordinators, CTA coordinator Support). You will be also responsible to prepare/submit to Regulatory Authorities the regulatory dossiers related to Clinical studies on any Sanofi Investigational medicinal products, combination products, medical devices for any interventional and non-interventional clinical studies (New initial CTAs, Amendments, Notifications, DSURs) for the United Kingdom and Switzerland within set timelines for approval. You will be driven to do meaningful tasks, having impact on peoples health and well-being, also will be a key member of a highly productive team, and demonstrate a strong drive for solving problems and enhancing operational methods.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
Management of the country CTA regulatory managers, CTA coordinator and the CTA coordinator support team in Hungary in collaboration with the CTA Governance Office team:Drive and monitor CTA activities managed by the Hungarian CTA team, prioritize their activities. Ensure a robust talent management process to develop, retain an effective Hungarian CTA group team.Support to the CTA Governance Office:Develop ways of working and quality metrics and contribute to continuous improvement of processes. Provide support for transversal activities under the lead of the CTA Governance OfficeResponsible for all the activities pertaining to Clinical Trial Applications to Regulatory Authorities in the United Kingdom and Switzerland:Prepare and submit CTA dossiers to Health Authorities (new initial CTAs, amendments, notifications, DSURs) for R&D and Medical Affairs, including application forms filling in line with the local regulations and in local languages when applicable, in close collaboration with the Global CTA team, and Clinical Study Unit team.Ensure that regulatory dossiers related to Clinical studies are submitted and approved in due time in line with local regulation and in local languages when applicable.Ensure liaison with the Corporate Global regulatory Team and Clinical teams for all CTA activities especially handling of questions from Health Authorities. Liaise with Health Authority and develop relations with key Regulatory authorities at country level.Be the focal point for Global Regulatory team to discuss strategies for clinical trial application. Be responsible for local regulatory risk assessment and management.Track all regulatory actions and ensure electronic archiving in appropriate databases.Regulatory Intelligence:Perform Regulatory Intelligence and regulatory requirements watch and ensure country regulatory portal is up to date. Analyse and communicate any changes in the CTA regulatory area and liaises with pertinent Sanofi functions to ensure implementation of new ways of working as per need.
About you
Experience :5 years of regulatory experience in CTA.Proven track record in leading teams and developing people, at least on a project management basis.Experience working within an international company with a complex organizational environment.Working knowledge of clinical trial design and developmentKnowledge and expertise of United Kingdom and/or Switzerland CTA regulations is a plusSoft skills :Strong negotiation, communication and influencing skills.Proficient working in a matrix environment and display the necessary multicultural sensitivity.Good organizational, analytical and planning abilities, results oriented.Problem solver with proactive mindset, able to prioritize and good with time management.Ability to manage multi projects.
Technical skills:
Good IT skills in, e.g. MS Office are essential, for planning, tracking, communicating and reporting.Education : Pharmacist / Scientist or other degree with first experience in Regulatory Affairs or other relevant experience.Languages : Fluency in English.
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team in an international work environmentWork from an "Office of the Year 2023" award winner with flexible home office policyEnjoy a thoug