Principal Regulatory Writer, Global Rare Diseases
Salva questo lavoro e mantieni la tua ricerca organizzata
Crea un account gratuito per salvare lavori, creare avvisi e tornare a questa inserzione dalla tua dashboard.
In this role you will author, review, and manage regulatory documents that translate clinical, nonclinical, and CMC data into compliant submissions for global authorities. You will serve on cross-functional teams to ensure scientific rigor and regulatory alignment across the product lifecycle. You’ll oversee document development for marketing applications and lifecycle updates, while guiding external writers and internal experts. This is a chance to shape regulatory strategy for rare diseases within a mission-driven, globally integrated environment.
Retribuzione / Benefits- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- relocation support
- annual bonus
- Draft, review, and finalize regulatory and clinical documents (CTD Modules 1-2 and related addenda)
- Coordinate post-approval variations and lifecycle documentation
- Prepare regulatory response documents (RFI, Questions, Objections) and designation/expedition requests
- Develop and maintain clinical study protocols and reports, investigator brochures
- Ensure eCTD compliance and alignment with ICH/FDA/EMA guidelines
- Lead and coordinate external writers and internal SMEs; mentor junior writers
- Support dossier assembly, timelines, and cross-functional inputs; contribute to resource planning and budgeting
- Train contributors on regulatory writing standards, styles, and traceability
- Life science university degree; PhD or PharmD preferred
- Experience authoring/regulatory writing across drug development lifecycle
- Knowledge of FDA/EMA requirements and ICH guidelines (E3, E6, E9, M4)
- Ability to interpret clinical/statistical data for regulatory submissions
- Fluent English, strong written and verbal communication
- Experience with cross-functional team leadership and project management
- Proficient in MS Office and Adobe Acrobat; familiarity with eCTD publishing
- exceptional written and verbal communication
- highly organized and proactive
- attention to detail
- global regulatory frameworks (FDA, EMA)
- ICH guidelines (E3, E6, E9, M4)
- regulatory writing best practices and templates
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoAbout usChiesi 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...
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoChiesi Global Rare Diseases is seeking a Principal Regulatory Writer based in Italy to author, review, and manage regulatory documents for global submissions. You will coordinate cross-functional teams, ensure eCTD compliance, and supervise external writers to meet timelines.The role requires a life science degree, fluency in English, and strong experience...
-
Reggio Emilia, Emilia-Romagna, Italia Chiesi Tempo pienoOverview In this role you will provide statistical leadership across drug development programs, guiding study design, analysis, and regulatory submissions. You will collaborate with cross-functional teams to ensure rigorous, fit-for-purpose data interpretation and communicate complex results to non-statistical stakeholders. You will oversee statistical...
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoChiesi seeks a Regulatory Affairs (RA) Senior Manager with strong CMC pre/post-approval experience to support the Global Rare Diseases portfolio. You will lead CMC documentation, author sections, and advise on regulatory strategies across global submissions.The role emphasizes collaboration with cross-functional teams, external CMOs, and continuous learning...
-
Reggio Emilia, Emilia-Romagna, Italia Chiesi Tempo pienoOverview In this role you will support Chiesi’s Global Rare Diseases portfolio by managing CMC regulatory activities across submissions and lifecycle. You will collaborate with Core teams, GCST, and external CMOs to ensure compliance and timely regulatory deliverables. You will influence regulatory strategy and lead documentation for marketing...
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoAbout usChiesi 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...
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoChiesi Global Rare Diseases in Europe seeks a Medical Monitor/Clinical Research Physician to support global clinical studies in rare diseases. You will contribute to study design, risk/benefit assessments, and regulatory document preparation, while ensuring scientific validity and timely publication.Applicants should have a Medical Doctor degree, 2+ years as...
-
Reggio Emilia, Emilia-Romagna, Italia Chiesi Tempo pienoOverview In this role you drive clinical development by supporting global studies and ensuring scientific soundness. You work with cross-functional teams to shape trial design, endpoints and monitoring strategies, while interfacing with health authorities and external experts. You contribute to regulatory documents and publication plans, helping grow our...
-
reggio emilia, emilia romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoClinical Research Physician, Global Rare Diseases Department: GRD Clinical Development Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Europe (flexible) – remote or hybrid What you will do Support the clinical team in relevant medical and scientific aspects of the assigned global...
-
reggio emilia, emilia romagna, Italia Biopharma Careers Tempo pienoAbout usChiesi 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...
