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About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for
Do you want to be part of establishing Chiesi Global Regulatory Affairs in Sweden? Chiesi Global Regulatory Affairs is looking for a Global Regulatory Lead based in Stockholm with a focus on Neonatology and Special Care.
This position as Senior Global RA Manager is assigned as Global Regulatory Lead to R&D projects in development and during life-cycle management. This involves leading the Global Regulatory Teams and be the regulatory representative on the Core Teams for assigned projects.
The Senior Global RA Manager is accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) and being the regulatory representative on the global core team for assigned projects. The Senior Global RA Manager will manage and lead the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards. A main responsibility is also to ensure that regulatory strategies are innovative and robust.
The Senior Manager will manage pre-approval and post approval activities in collaboration with the GRT and its members. A key aspect is to maintain relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements to guide and advise clinical, pre-clinical and CMC development for the success of the development program. The Senior Manager will also provide support to affiliates, and partners for prioritized issues and topics and build close relationships with R&D functions, and key stakeholders in the Franchises.
Within GRA the Sr Manager will also be a key contributor for due diligence projects and other cross-company initiatives.
At least ten years of experience within Regulatory Affairs of which at least five in a regional or global context.
University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
Written and spoken English for professional purposes.
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
