Senior Regulatory Writer & Project Lead

Certara; United Kingdom; On-site; GBP 55,000 - 75,000; Full time

Job summary

A leading strategic drug development firm in the United Kingdom seeks an Associate Principal Regulatory Writer. The role involves authoring high-quality documents for regulatory submissions, leading project teams, and collaborating closely with clients. The ideal candidate will have over 5 years of regulatory writing experience, a Bachelor’s degree or higher, and strong skills in document preparation. This position offers a chance to impact drug development positively, working in a collaborative environment.

Qualifications

• 5-8+ years of regulatory writing experience or equivalent.
• Experience in the development of submission-level documents.
• Understand regulatory authority guidelines.

Responsibilities

• Work closely with client to lead development of regulatory documents.
• Author documents per client specifications and regulatory guidelines.
• Manage budget for low complexity projects.

Skills

Intermediate proficiency with Microsoft Word

Strong understanding of the document creation process

Ability to synthesize data

Expertise in quality document preparation

Ability to lead complex projects

Problem-solving skills

Development of professional client relationships

Education

Bachelor’s degree; MS or PhD preferred

Job description

A leading strategic drug development firm in the United Kingdom seeks an Associate Principal Regulatory Writer. The role involves authoring high-quality documents for regulatory submissions, leading project teams, and collaborating closely with clients. The ideal candidate will have over 5 years of regulatory writing experience, a Bachelor’s degree or higher, and strong skills in document preparation. This position offers a chance to impact drug development positively, working in a collaborative environment.