Senior Remote Clinical Regulatory Writer

Med Communications International; Lisboa; Remote; EUR 50,000 - 75,000; Full time

Job summary

Med Communications International is seeking a Regulatory Writing Specialist (Clinical) with 3+ years of hands-on pharmaceutical regulatory writing experience. The role involves authoring CSRs, clinical protocols, IBs, and CTD Module 2 documents, plus coordinating client-facing projects and QC reviews.

The position supports regulatory submissions (IND/NDA/BLA/MAA), nonclinical writing, and collaboration with cross-functional teams. Remote - Europe.

Qualifications

• 3+ years hands-on pharmaceutical regulatory writing experience with substantive document authorship.
• Direct authorship of multiple regulatory documents and client-facing project management experience.
• Experience with regulatory submissions (IND, NDA, BLA, MAA) and CTD Module 2 documents.
• Strong document QC, attention to detail, and scientific writing skills.
• Excellent written English and scientific communication.
• Familiarity with ICH guidelines and FDA/EMA requirements.
• Ability to work independently in a regulatory environment.

Responsibilities

• Author CSR, clinical protocols, IBs, briefing documents and other regulatory reports.
• Prepare and support IND/NDA/BLA/MAA submissions including CTD Module 2 documents.
• Develop nonclinical summaries and CTD Modules 2.4/2.6/4 when applicable.
• Collaborate with internal teams and clients to manage reviews and revisions.
• Conduct QC reviews to ensure accuracy, consistency and compliance.
• Coordinate deliverables to meet project timelines with cross-functional teams.

Skills

Regulatory writing

Clinical writing

CSR writing

CTD Modules

Document QC

Project management

English writing

Word formatting

ICH guidelines

Tools

Veeva Vault

SharePoint

PleaseReview

Job description

Med Communications International is seeking a Regulatory Writing Specialist (Clinical) with 3+ years of hands-on pharmaceutical regulatory writing experience. The role involves authoring CSRs, clinical protocols, IBs, and CTD Module 2 documents, plus coordinating client-facing projects and QC reviews.

The position supports regulatory submissions (IND/NDA/BLA/MAA), nonclinical writing, and collaboration with cross-functional teams. Remote - Europe.