Lead Regulatory Writer & Submissions Strategy

Certara; United Kingdom; On-site; GBP 65,000 - 80,000; Full time

Job summary

A leading drug development consulting firm in the United Kingdom is looking for an experienced Associate Principal Regulatory Writer. The role involves leading project teams in preparing high-quality regulatory documents, mentoring junior staff, and managing project budgets. Candidates should have a Bachelor's degree, a minimum of 8 years of regulatory writing experience, and strong proficiency in Microsoft Word. Join us to contribute to advancing critical therapies for patients.

Qualifications

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

Responsibilities

• Prepare high quality documentation for regulatory submissions.
• Lead development of strategies for organizing regulatory documents.
• Manage budget for low complexity projects.

Skills

Intermediate proficiency with Microsoft Word

Strong understanding of the document creation process

Ability to synthesize data across multiple sources

Expertise in quality document preparation

Ability to own submission-level sections

Understanding of communication best practices

Education

Bachelor’s degree; MS or PhD preferred

Job description

A leading drug development consulting firm in the United Kingdom is looking for an experienced Associate Principal Regulatory Writer. The role involves leading project teams in preparing high-quality regulatory documents, mentoring junior staff, and managing project budgets. Candidates should have a Bachelor's degree, a minimum of 8 years of regulatory writing experience, and strong proficiency in Microsoft Word. Join us to contribute to advancing critical therapies for patients.