Remote Senior Nonclinical Writer – Lead Reg Submissions (UK)

MMS; Belfast City District; Remote; GBP 55,000 - 75,000; Full time

Job summary

MMS is seeking a remote-based Senior Regulatory Nonclinical Writer in the UK to develop and manage highly technical nonclinical documents for regulatory submissions. The role requires leading projects, coordinating with cross-functional teams, and ensuring compliance with GLP, ICH, FDA, and EMA guidelines.

Applicants should have a BS in pharmacology/toxicology/biology/chemistry and 5+ years of regulatory writing experience. This is a full-time remote position suitable for UK-based candidates.

Qualifications

• BS+ in pharmacology, toxicology, biology or chemistry, or related field with industry experience in regulatory writing/regulatory affairs.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Strong writing and analytical skills.
• Proficiency with MS Office applications.

Responsibilities

• Lead development, writing, and management of highly technical nonclinical documents (e.g., Module 2.4 and 2.6 eCTD submission documents, IB, Nonclinical Study Reports).
• Lead projects independently with minimal oversight, ensuring alignment with regulatory guidelines and scientific integrity.
• Author based on highly technical sources such as GLP and non-GLP nonclinical data (in vivo and in vitro).
• Develop a mapping plan for placement of nonclinical studies within Module 2.4 and 2.6 eCTD submission documents.
• Interpret and analyze PK/PD/toxicology data and related reports.
• Collaborate with cross-functional teams (project management, safety, regulatory operations, CMC).
• Demonstrate ability to lead others to complete complex projects.

Skills

Regulatory writing

Nonclinical

Project management

Cross-functional collaboration

Regulatory guidelines

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

MS Office

SharePoint

Veeva RIM

EndNote

Job description

MMS is seeking a remote-based Senior Regulatory Nonclinical Writer in the UK to develop and manage highly technical nonclinical documents for regulatory submissions. The role requires leading projects, coordinating with cross-functional teams, and ensuring compliance with GLP, ICH, FDA, and EMA guidelines.

Applicants should have a BS in pharmacology/toxicology/biology/chemistry and 5+ years of regulatory writing experience. This is a full-time remote position suitable for UK-based candidates.