Regional Regulatory dossier Expert-AMEE Region
The AMEE RA COE Country associate will be responsible for the post-approval changes dossier evaluation, preparation, and dispatch to the countries for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory team. The AMEE RA COE Country associate will report to the AMEE RA COE Cluster Manager or Head.
- According to the country regulatory requirements and planning, assess, coordinate, and contribute to the preparation of ready- to- submit regulatory dossier: Labeling, CMC, administrative, renewal /annual report, Site registration, Tender and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.
- Ensure regulatory compliance with products overall strategies and Health authorities country requirements evolution
- Be compliant with all internal and external requirements, procedures, and tools,
- Implement in timely manner Regional BU/country planning dispatch and ensure alignment with RA BU region and country activities
- Maintain a good working relationship with internal and external stakeholders, be a business partner for the BU/Country regulatory team
- Foster an environment/culture of learning and sharing of best practice within the team
- Fluent in English and in the specific language of the cluster
- Minimum of 3 – 4 years experiences in, Regulatory Affairs, Quality Assurance in international or local regulatory affairs.
- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy, and rigor
- Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.
- Project management experience in the pharmaceutical industry or in a regulatory environment.
- Knowledge in regulatory requirements and Good Manufacturing practices of the cluster
About Sanofi and Global Regulatory Affairs
In 2019 Sanofi Hungary was awarded Top Employer for the 2nd time while the same year Sanofi received the Global Top Employer award the 1st time in history. / while the same year Sanofi became a certified Global Top Employer the 1st time in history.
Sanofi is a global pharmaceutical leader providing healthcare solutions in more than 170 countries around the world. Sanofi has over 100 000 employees representing 145 nationalities worldwide.
At Sanofi’s Global Regulatory Affairs, we’re ushering in a bold new era of regulatory affairs – one that is rooted in collaboration, driven by creativity, and inspired by tomorrow. As strategic partners with our 1.400 RA associated present in over 80 countries, we build regulatory strategies and timely execute our targets while establishing constructive relationships with health authorities and key stakeholders worldwide. We’re harnessing cloud-based systems and advanced technology to amplify the impact of our ambitious teams.
Are you looking for an opportunity to contribute to an agile, global regulatory team? To impact a broad and diverse portfolio of hundreds of products? To drive change at a company that is 100% full-scale all-in committed to transforming its technology base and reimagining the role of regulatory affairs? Apply to join our regulatory Hub and discover all that you can do.”
The offices of Sanofi GRA Hub are in Váci Greens, in the heart of one of Budapest’s most famous business districts. The site offers a comfortable, sustainable and friendly working environment with community areas, gardens and bicycle storage. It is easily accessible by transportation; the site is between Gyöngyösi utca and Forgách utca metro stations.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.