English-writer

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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger. Chiesi Global Rare DiseasesChiesi 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. What we are looking forThis is what you will doWithin the Global Rare Diseases, R&D, Regulatory Affairs and reporting to the VP, Global Regulatory Affairs, Global Rare Diseases the Principal Regulatory Writer is responsible for authoring, reviewing, and managing regulatory documents that translate clinical, nonclinical and CMC data into clear, accurate, and compliant submissions for global health authorities (e.g., FDA, EMA, MHRA, NMPA, Health Canada), supporting both initial marketing applications and post‐approval lifecycle activities for drugs and biological products. They serve as a central member of cross‐functional regulatory submission teams, working in close collaboration with Global and Regional Regulatory Leads, Clinical Development, Biostatistics, Safety/Pharmacovigilance, CMC, Medical Affairs, and external partners to ensure consistency, scientific rigor, and regulatory alignment. They are accountable for document development across the full product lifecycle, including original applications, variations/supplements, responses to regulatory questions, periodic updates, other post-approval life cycle management documents. They provides coordination, oversight, and guidance for regulatory writing activities across Global Rare Disease (GRD) development programs, ensuring harmonization of messaging and adherence to global standards. You will be responsible forOversee the drafting, review, and finalization of key regulatory and clinical documents, including but not limited to: CTD Module 1 and 2 documents, including:1.6.1 and 1.6.2 (Meeting requests and packages) .
Nonclinical and Clinical summaries and overviews)Addenda, updates, consolidation, alignment of Module 2 documents required to support post‐approval variations, extensions, or annual benefit–risk reassessmentsRegulatory response documents, including responses to Questions, Information Requests, Requests for Information (RFIs), Major Objections, Clarifaxes, and List of Outstanding IssuesDocuments of required for clinical development and post-approval life cycle management, including clinical study protocols, clinical study reports, investigator's brochures,Expedited and Special Program applications (e.g. Orphan Designation Requests, Rare Pediatric Disease Designation Requests, RMAT, Breakthrough, Fast Track, PRIME, Sakigake, Priority Review Voucher RequestsEnsure all regulatory documents are fully compliant with eCTD specifications and applicable regional and international guidelines (e.g., In collaboration with Global Regulatory Leads and Regional Regulatory Leads, support timely and high‐quality dossier assembly and submission, managing document timelines and cross‐functional inputs. Provide subject-matter expertise and leadership in the development, maintenance, and implementation of role‐relevant tools, SOPs, work instructions, templates, and style guides. Train and guide cross‐functional contributors on best practices for regulatory writing, including adherence with Chiesi standards and styles, document structure, data presentation, traceability, and version control. Contribute to resource planning, ensuring adequate FTE and budget support to meet program and organizational regulatory writing needs. You will need to haveRelevant life science university degree, PhD or Pharm. RAC PreferredDemonstrated experience authoring and/or leading the development of regulatory documents across the drug development lifecycle, such as: Health Authority Meeting Requests, Packages, Briefing Documents; IND, CTA, NDA/BLA modules)Background knowledge in rare diseases is highly desirableFluent in both the written word and spoken EnglishTechnical SkillsStrong familiarity with global regulatory frameworks and expectations, including FDA and EMA requirementsAdvanced knowledge of ICH guidelines governing regulatory document structure, format, and content, including but not limited to ICH E3, E6, E9, and M4Strong understanding of