Country Clinical Trial Application (CTA) Regulatory Manager Team Lead

Job title:

Country Clinical Trial Application (CTA) Regulatory Manager Team Lead

Company:

Sanofi

Job description

• Location: Budapest
• Job type: Permanent, Full-time
• Hybrid working according to local policy

About the jobAre 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 people’s 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 people’s lives. We’re 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 Office

Responsible 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 youExperience:

• 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 development
• Knowledge and expertise of United Kingdom and/or Switzerland CTA regulations is a plus

Soft 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 environment
• Work from an “Office of the Year 2023” award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress. Discover Extraordinary.Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !Discover our , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.#Sanofi #SanofiCareers #joinSanofi#jobopportunities #careeropportunities #sscjob#Sanofi_Budapest_Hub #Budapest#Regulatory #regulatoryaffairs #clinicaltrialapplication #CTA #Regulatorylead #regulatoymanager#LI-EUR #LI-hybridPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

Expected salary

Location

Budapest

Job date

Wed, 12 Feb 2025 23:13:27 GMT

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