Senior Regulatory Writing Lead — Remote Europe

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

Job summary

Med Communications International seeks a Senior Regulatory Writing Specialist (Consultant) to lead regulatory writing projects for investigational and marketed products, ensuring alignment with regulatory requirements across ICH, FDA, and EMA guidance. The role collaborates with client teams to manage study documents and timelines while maintaining high quality.

Remote work is supported across Europe. Ideal candidates have an advanced degree in life sciences or equivalent, 3–5 years in

Qualifications

• 3–5 years regulatory writing experience.
• Mastery of 3+ regulatory document types.
• Knowledge of ICH, FDA, EMA guidelines.
• Leads cross-functional document review meetings.

Responsibilities

• Regulatory writing for protocols, reports, and IND/NDA/MAA components.
• Manage timelines and lead project meetings.
• QC documents for abbreviations, data, and references.
• Guide less experienced writers on documents.

Skills

Regulatory writing

Project management

Attention to detail

Cross-functional collaboration

Time management

Education

Advanced degree in life sciences

Relevant work experience

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Med Communications International seeks a Senior Regulatory Writing Specialist (Consultant) to lead regulatory writing projects for investigational and marketed products, ensuring alignment with regulatory requirements across ICH, FDA, and EMA guidance. The role collaborates with client teams to manage study documents and timelines while maintaining high quality.

Remote work is supported across Europe. Ideal candidates have an advanced degree in life sciences or equivalent, 3–5 years in