Senior Nonclinical Regulatory Writer — Remote UK

MMS Holdings Inc; Manchester; Remote; GBP 60,000 - 90,000; Full time

Job summary

MMS Holdings Inc. in the United Kingdom seeks an experienced regulatory writer to develop and manage highly technical nonclinical documents for regulatory submissions.

You will lead projects independently and collaborate with cross-functional teams to ensure documentation meets current guidelines. You will work on modules 2.4/2.6, IBs, and nonclinical study reports, with emphasis on GLP and ICH considerations.

Qualifications

• BS in pharmacology, toxicology, biology or chemistry with regulatory writing experience.
• Knowledge of GLP, ICH guidelines and regulatory requirements.
• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Proficiency in MS Office applications.

Responsibilities

• Develop and manage nonclinical submission documents (Module 2.4/2.6).
• Lead writing of INDs/CTAs/NDAs/BLAs/MAAs nonclinical packages.
• Interpret GLP and non-GLP data and prepare PK/TK evaluations.
• Collaborate with cross-functional teams across PM, safety, regulatory operations.

Skills

Regulatory writing

Analytical skills

Project management

Communication

Team collaboration

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

MS Office

SharePoint

Veeva RIM

EndNote

Job description

MMS Holdings Inc. in the United Kingdom seeks an experienced regulatory writer to develop and manage highly technical nonclinical documents for regulatory submissions.

You will lead projects independently and collaborate with cross-functional teams to ensure documentation meets current guidelines. You will work on modules 2.4/2.6, IBs, and nonclinical study reports, with emphasis on GLP and ICH considerations.