Regulatory Documentation Specialist (Contract)
Pharmaceutical / Biotechnology Sector
Remote or Hybrid (Welwyn Garden City - 2 days per week if hybrid)
Outside IR35
12-Month Contract
We are seeking an experienced Regulatory Documentation Specialist to support global regulatory submissions within a leading pharmaceutical environment.
This is a senior-level contract opportunity suited to a regulatory medical writer or content strategist with strong experience in clinical and safety documentation across the product lifecycle.
The Role
You will lead the development and execution of regulatory content strategies for global submissions, ensuring high-quality, compliant, and strategically aligned documentation.
Key responsibilities include:
* Leading the preparation and review of clinical dossiers, safety reports, and other regulatory submission documents
* Defining and executing content strategy for global health authority submissions
* Planning document timelines and coordinating cross-functional contributors
* Ensuring clarity, scientific accuracy, and consistency of messaging across all materials
* Reviewing documents for compliance with global regulatory standards (GxP, GCP, ICH, MDR/IVDR, etc.)
* Collaborating with clinical, safety, and regulatory teams in a matrix environment
* Supporting global filings and submission activities
* Contributing to continuous improvement of regulatory documentation processes
* Mentoring or supporting junior content strategists where applicable
Required Experience
* Degree in Life Sciences or equivalent
* Minimum 5 years' experience in pharmaceutical or biotechnology industry
* Strong experience in regulatory medical writing or regulatory content strategy
* Demonstrated expertise in clinical, safety, or device regulatory documentation across the product lifecycle
* Knowledge of global/regional drug or device development regulations (GxP, GCP, ICH, ISO, MDR/IVDR)
* Experience leading or contributing to global regulatory submissions
* Proven ability to work cross-functionally in matrixed teams
* Strong document planning and project coordination skills
* Proficiency with tools such as Veeva Vault, Microsoft Office, G Suite, and Adobe Acrobat
* Fluent written and spoken English
Desirable
* Experience driving outcomes in global filings
* Experience mentoring or leading other medical writers/content strategists
* Experience in highly matrixed global pharmaceutical environments