Senior Regulatory Writer – Clinical Submissions Lead

Certara; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global biopharmaceutical organization is seeking a Senior Regulatory Writer to lead and participate in project teams focused on regulatory documentation. Candidates should have at least 3 years of regulatory writing experience and a Bachelor's degree. This role involves authoring documents per client specifications and regulatory guidelines, managing project budgets, and coaching junior staff. The ideal candidate will demonstrate strong Microsoft Word proficiency and an understanding of the drug development lifecycle. Competitive salary and opportunities for professional growth are offered.

Qualifications

• 3+ years of regulatory writing experience or equivalent experience with clinical documentation.
• Experience in developing submission-level documents.
• Knowledge of regulatory authority guidelines.

Responsibilities

• Lead project teams and author regulatory documents.
• Manage budgets for low complexity projects.
• Provide coaching to junior staff.

Skills

Intermediate proficiency with Microsoft Word

Understanding of drug development lifecycle

Ability to synthesize data

Strong problem-solving skills

Effective communication

Education

Bachelor's degree

Job description

A global biopharmaceutical organization is seeking a Senior Regulatory Writer to lead and participate in project teams focused on regulatory documentation. Candidates should have at least 3 years of regulatory writing experience and a Bachelor's degree. This role involves authoring documents per client specifications and regulatory guidelines, managing project budgets, and coaching junior staff. The ideal candidate will demonstrate strong Microsoft Word proficiency and an understanding of the drug development lifecycle. Competitive salary and opportunities for professional growth are offered.