Senior Regulatory Writing Consultant (Remote Europe)

Med Communications International; Lisboa; Remote; EUR 65,000 - 90,000; Part time

Job summary

Med Communications International seeks a Senior Regulatory Writing Specialist (Consultant) to create regulatory documents for investigational and marketed products in line with regulatory practices. You will collaborate with client teams to manage regulatory writing projects from initiation to submission.

The role requires an advanced degree in life sciences, 3–5 years of regulatory writing experience, and fluent English (C1/C2).

Qualifications

• Advanced degree in a scientific discipline or relevant work experience.
• 3–5 years of regulatory writing experience.
• Fluent in English (C1/C2).
• Experience authoring regulatory documents: protocols, CSRs, briefing documents, IND/NDA/MAA components.

Responsibilities

• Create regulatory documents for investigational and marketed products.
• Lead cross‑functional document reviews and ensure accuracy and consistency.
• Manage timelines and project plans for regulatory writing projects.
• Support SOPs, templates, and regulatory writing style guides.

Skills

Regulatory writing

Project management

Attention to detail

Communication

Education

Advanced degree in life sciences/pharmacy/medicine

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Med Communications International seeks a Senior Regulatory Writing Specialist (Consultant) to create regulatory documents for investigational and marketed products in line with regulatory practices. You will collaborate with client teams to manage regulatory writing projects from initiation to submission.

The role requires an advanced degree in life sciences, 3–5 years of regulatory writing experience, and fluent English (C1/C2).