Senior Clinical Regulatory Writer - Remote (Europe)

Med Communications International; Lisboa; Remote; EUR 60,000 - 90,000; Full time

Job summary

Med Communications International in Europe is seeking a Regulatory Writing Specialist with at least 3 years of hands-on pharmaceutical regulatory writing experience, including clinical study reports, protocols, IBs, and CTD Module 2 documents. The role focuses on authoring, QC, and coordinating client-facing regulatory deliverables for submissions (IND/NDA/BLA/MAA).

You will work remotely across Europe, liaise with cross-functional teams, and ensure quality and timely delivery of regulatory

Qualifications

• 3+ years hands-on pharmaceutical regulatory writing with substantive document authorship.
• Direct authorship of at least 3 regulatory document types (CSR, protocols, IB, etc.) with client-facing/project management experience.
• Practical document QC review experience and excellent attention to detail.
• Advanced Microsoft Word skills with complex formatting and tracked changes.
• Excellent written English, scientific communication, and organizational skills.

Responsibilities

• Author and develop Clinical Study Reports (CSRs), study protocols, IBs, briefing documents, and other clinical regulatory documents.
• Prepare and support documentation for IND, NDA, BLA, and MAA submissions including CTD Module 2 documents.
• Develop nonclinical summaries and CTD Module 2.4/2.6/4 documents where applicable.
• Work with clinical evidence reports, source materials, and CMC documentation as needed.
• Conduct QC reviews to verify accuracy, references, data, tables, and formatting.
• Liaise with clients and cross-functional teams to manage review comments and deliverables on time.

Skills

Regulatory writing

Clinical regulatory writing

CSR

Clinical protocols

Investigator's Brochure

CTD Module 2

Module 2.4

Module 2.5

Module 2.6

Module 2.7

Module 4

IND

NDA

BLA

MAA

CMC

Document QC

Regulatory submissions

Microsoft Word

Veeva Vault

SharePoint

PleaseReview

ICH Guidelines

FDA

EMA

Biostatistics

Tools

Veeva Vault

PleaseReview

SharePoint

Job description

Med Communications International in Europe is seeking a Regulatory Writing Specialist with at least 3 years of hands-on pharmaceutical regulatory writing experience, including clinical study reports, protocols, IBs, and CTD Module 2 documents. The role focuses on authoring, QC, and coordinating client-facing regulatory deliverables for submissions (IND/NDA/BLA/MAA).

You will work remotely across Europe, liaise with cross-functional teams, and ensure quality and timely delivery of regulatory