Description

You will author high-quality Module 2 and 3 regulatory submissions for development and post-approval dossiers.

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.
• Chemistry, Manufacturing and Controls (CMC) experience.
• 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.
• Exposure to non-US regulatory activities.
• Expertise with Veeva or Documentum.

Key Skills

Education

Any Graduate