Senior Regulatory Writer - Clinical Submissions Lead

Certara Inc.; United Kingdom; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biopharmaceutical service provider in the United Kingdom is seeking an Associate Principal Regulatory Writer to lead the development of strategies for regulatory documentation. You will author critical documents to streamline the regulatory approval process and manage project budgets while ensuring compliance with guidelines. Ideal candidates will have extensive regulatory writing experience and strong skills in document management and data synthesis. This role offers opportunities to mentor junior staff and develop professional client relationships.

Qualifications

• 5-8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD.
• Understanding of regulatory authority guidelines and requirements.
• Experience in the development of submission-level documents.

Responsibilities

• Lead development of strategies for regulatory documents.
• Author documents per client specifications and regulatory guidelines.
• Manage budget for low complexity projects.
• Coach junior staff and ensure compliance with SOPs.

Skills

Microsoft Word proficiency

Document management techniques

Data synthesis

Expertise in document preparation

Communication best practices

Problem resolution

Technical expertise across therapies

Education

Bachelor’s degree; MS or PhD preferred

Job description

A global biopharmaceutical service provider in the United Kingdom is seeking an Associate Principal Regulatory Writer to lead the development of strategies for regulatory documentation. You will author critical documents to streamline the regulatory approval process and manage project budgets while ensuring compliance with guidelines. Ideal candidates will have extensive regulatory writing experience and strong skills in document management and data synthesis. This role offers opportunities to mentor junior staff and develop professional client relationships.