Principal Regulatory Writer, Global Rare Diseases

This is what you will do

Within 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 for

• Oversee 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) .
    • 2.4, 2.5, 2.7.3, 2.7.4, 2.7.5, 2.7.6 etc. (e.g. 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 reassessments
  • Regulatory response documents, including responses to Questions, Information Requests, Requests for Information (RFIs), Major Objections, Clarifaxes, and List of Outstanding Issues
  • Documents 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 Requests
• Ensure all regulatory documents are fully compliant with eCTD specifications and applicable regional and international guidelines (e.g., ICH, FDA, EMA).
• 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.
• Maintain awareness of current and evolving global regulatory requirements, proactively incorporating regulatory intelligence into authored submissions.
• Provide subject-matter expertise and leadership in the development, maintenance, and implementation of role‑relevant tools, SOPs, work instructions, templates, and style guides.
• Coordinate and manage external regulatory writers and internal subject matter experts, ensuring quality, consistency, and adherence to agreed timelines for marketing authorization and lifecycle submissions.
• 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 have

• Relevant life science university degree, PhD or Pharm. D in Biochemistry, Pharmacology, or a related field.  RAC Preferred
• Demonstrated experience authoring and/or leading the development of regulatory documents across the drug development lifecycle, such as: Health Authority Meeting Requests, Packages, Briefing Documents; Critical / Key Module 1 documents; Nonclinical and Clinical Overviews and Summaries (CTD Module 2); Response documents to regulatory authorities; Expedited and Special Program Requests and Designation Packages (e.g. Orphan Drug Designation Requests, Fast Track, Prime, RMAT, Breakthrough, Sakigaki, etc.); Clinical Trial Applications/Dossiers (e.g., IND, CTA, NDA/BLA modules)
• Background knowledge in rare diseases is highly desirable
• Fluent in both the written word and spoken English

Technical Skills

• Strong familiarity with global regulatory frameworks and expectations, including FDA and EMA requirements

• Advanced knowledge of ICH guidelines governing regulatory document structure, format, and content, including but not limited to ICH E3, E6, E9, and M4
• Strong understanding of the end to end drug development process, regulatory strategy considerations, and the informational needs of internal and external stakeholders
• Proficient in interpreting complex clinical and statistical data, with the ability to present results clearly, convincingly, and concisely in a regulatory context
• Advanced proficiency in MS Office applications (Word, PowerPoint, Excel, Teams) and Adobe Acrobat, including document formatting, review, and alignment with eCTD requirements to facilitate efficiency in the publishing of regulatory submissions

Soft Skills

• Exceptional written and verbal communication skills, with the ability to convey complex scientific and regulatory concepts clearly to both technical and non technical audiences
• Highly organized and proactive, with the ability to manage multiple deliverables under tight timelines while maintaining high standards for quality and compliance
• Excellent attention to detail, including data consistency, traceability, and alignment across submission documents
• Proven ability to build, guide, and maintain cohesive and collaborative teams, including mentoring junior writers and contributors (candidates with leadership development aspirations will be considered)
• Strong motivation, coordination, and conflict resolution skills within a matrixed, cross functional environment
• Excellent problem solving skills and the ability to work both independently and collaboratively in multidisciplinary teams

Compensation Range (Package for role based in Italy)

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. 

Location

The role can be based in the HQ in Parma or in one of Chiesi affiliates in Europe