Questa posizione è in Chiesi Group Riassunto dell'opportunità da parte della Joinrs AI : Chiesi Group cerca un Senior Manager, CMC Regulatory Affairs con almeno 7 anni di esperienza in Regulatory CMC , di cui 3 + in Biologics/Biopharmaceuticals, per supportare il portfolio globale di Global Rare Diseases.
Il ruolo prevede la gestione autonoma di documenti regolatori CMC, il coordinamento con team multidisciplinari e negoziazioni con le autorità regolatorie.
La posizione offre una retribuzione minima di €****** per l'Italia, un bonus annuale e un pacchetto di benefit comprensivo di assicurazioni e programmi di benessere.
Il processo di selezione sarà interamente gestito da Chiesi Group.
-- Senior Manager, CMC Regulatory Affairs, Global Rare Diseases Date: 17 Jun **** Department: GRD Regulatory Affairs Business Area: R Advanced Degree strongly preferred 7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered) Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements Sound knowledge of manufacturing technical transfer and comparability regulatory requirements Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system Strong attention to detail Ability to multi-task, stay organized and prioritize Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems Ability to work independently and in a group setting and thrive in a fast-paced environment Location The role can be based in one of our affiliates in Europe.
Compensation (package applied for role based in Italy) The minimum salary for this role is €******, 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 premio scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package 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.
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📌 Senior Manager, Cmc Regulatory Affairs, Global Rare Diseases (Parma)
🏢 Chiesi Group
📍 Parma