Description

You will author high-quality Module 2 and 3 regulatory submissions for development and post-approval dossiers, ensuring compliance with US, EU, and global standards. You will own the creation of content from source documentation, manage change controls, and produce white papers and technical reports. You will recommend tables of contents for submissions, identify regulatory risks to support strategy, and author responses to health authority questions. Additionally, you will maintain up-to-date knowledge of Common Technical Document (CTD) templates and document management systems.

Responsibilities

• Author Module 2 and 3 regulatory submissions, change controls, white papers, position papers, and technical reports.
• Create content from source documentation for US, EU, and rest of world (ROW) dossiers.
• Recommend tables of contents for regulatory submissions and identify potential regulatory risks to support strategy.
• Ensure dossier compliance and author responses to questions from health authorities.
• Maintain up-to-date knowledge of Common Technical Document (CTD) templates and document management systems.

Required Skills

• 5+ years of industry experience in regulatory affairs or technical writing.
• Chemistry, Manufacturing and Controls (CMC) experience.
• Deep knowledge of Common Technical Document (CTD) structures.
• Knowledge of US pharmaceutical regulations.
• Proficiency with MS Office, including Word and Excel.
• Experience using document management systems.
• Degree (BS/BA, MS, or PhD) in a science or health field such as Biology, Analytical Chemistry, or Pharmacy.

Preferred Skills

• Background in pharmaceutical manufacturing, quality control, or quality assurance.
• Working knowledge of cGMPs.
• Experience with CMC documentation for various dosage forms.

Key Skills

Education

Any Graduate