Regulatory Writer

View full description

Requirements:

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• 3+ years of experience in regulatory writing within the pharmaceutical or biotech industry.
• Proven expertise in preparing regulatory documents for submission to health authorities.
• Exceptional writing and editing skills with a strong attention to detail.
• Ability to distill complex scientific data into clear and concise language.
• Strong organizational and time management skills to handle multiple projects simultaneously.
• Proficient in Microsoft Office Suite and document management systems.
• Desirable: Familiarity with eCTD submission formats, and certification in regulatory writing or related field.

Responsibilities:

• Write, edit, and review regulatory documents, including INDs, BLAs, CTDs, and clinical study reports.
• Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance, to gather necessary information for document preparation.
• Ensure all documents are compliant with relevant regulatory guidelines and company standards.
• Conduct literature searches and summarize findings to support regulatory submissions.
• Monitor project timelines and deliverables, ensuring timely submission of documents.
• Maintain a thorough understanding of regulatory requirements and updates related to document preparation.
• Participate in meetings with regulatory agencies as needed to provide clarification on submitted documents.