Manager, EU & International Regulatory Affairs, Global Rare Diseases

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here. What we are looking for This is what you will do Reporting to the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, the Manager, EU & International Regulatory Affairs develop regulatory strategies for EU & International markets to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives. You will be responsible for In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products. Contribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation In agreement with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission. Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, provide regulatory guidance to colleagues from other functional areas Provide regulatory expertise in support of due diligence assessments Represent the Regulatory Department at the Core Team as a global RA member, where needed Support the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases in the preparation of the needed documents for the meetings and interactions with regional regulatory authorities You will need to have 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug development Life Science Degrees Flexible, collaborative, open minded Well-developed written and oral communication and listening skills Time management skills and demonstrated ability to manage complex assignments Well-developed analytical and problem-solving skills Ability to work independently and as part of a team We would prefer for you to have Experience in leadership and coaching is an asset Location The role can be based in the HQ in Parma, Italy or in Dublin, Ireland

Compensation

Range (package applied for role based in Italy) The minimum salary for this role is €46.800, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. Apply To This Job