Regulatory Affairs Writer

• Document Preparation: Write, edit, and review regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Clinical Study Reports (CSR).

• Regulatory Compliance: Ensure that all written materials comply with applicable regulations and guidelines from authorities such as the FDA, EMA, and ICH.

• Collaboration: Work closely with cross-functional teams, including regulatory affairs, clinical research, and quality assurance, to gather information and ensure the accuracy of content.

• Project Management: Manage multiple writing projects simultaneously, ensuring timely completion and adherence to submission deadlines.

• Quality Assurance: Conduct thorough reviews of documents for clarity, consistency, and compliance with regulatory standards.

• Research: Stay informed about current regulatory requirements and industry trends to ensure that all documents reflect the latest standards and practices.

• Training and Support: Provide guidance and training to team members on regulatory writing best practices and documentation standards.

• Bachelor’s degree in Life Sciences, Pharmacy, English, or a related field (Master’s degree preferred).

• Proven experience in regulatory writing within the life sciences industry.

• Strong understanding of regulatory requirements and guidelines.

• Excellent writing, editing, and communication skills.

• Detail-oriented with strong organizational and time management abilities.

• Ability to work independently and collaboratively in a fast-paced environment.

• Proficiency in relevant software and tools for document management and writing

Quantabase Technologies