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Location: Budapest
Flexible working: 60% home, 40% office
Job type: Permanent, Full-time
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 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:
Support to 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:
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 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 ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , 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.
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Pursue progress , discover extraordinary
Better 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 ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)