Principal Regulatory Writer, Global Rare Diseases

Principal Regulatory Writer, Global Rare Diseases focuses on 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.

What the role involves

• 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.
• Orphan Designation Requests, Rare Pediatric Disease Designation Requests, RMAT, Breakthrough, Fast Track, PRIME, Sakigake, Priority Review Voucher Requests.
• Support timely and high‑quality dossier assembly and submission, managing document timelines and cross‑functional inputs.
• Contribute to resource planning, ensuring adequate FTE and budget support to meet program and organizational regulatory writing needs.
• Relevant life science university degree, PhD or Pharm.
• Nonclinical and Clinical Overviews and Summaries (CTD Module 2).

Skills and requirements

• Advanced knowledge of ICH guidelines governing regulatory document structure, format, and content, including but not limited to ICH E3, E6, E9, and M4.
• Point, Excel, Teams) and Adobe Acrobat, including document formatting.

Confirmed role details

• The minimum .040, aligned to our established salary framework.
• 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.
• 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.

Additional role context

• 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.
• Develop, and market innovative drugs across our main therapeutic areas.