Key Accountabilities:

Submission Coordination:

• Assist in the preparation and coordination of regulatory submissions, including:

• Investigational New Drug (IND) applications
• Investigational Medicinal Product Dossiers (IMPDs)
• Post-approval commitments
• Annual reports
• Responses to regulatory authority questions

• Ensure all submissions are complete, accurate, and compliant with regulatory requirements
• Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation

Regulatory Assessment Support:

• Support the team in conducting regulatory assessments of manufacturing changes
• Analyze the potential impact of manufacturing changes on regulatory compliance
• Assist in preparing documentation to support manufacturing change assessments

Regulatory Compliance:

• Stay current with relevant regulations and guidelines
• Contribute to the development and maintenance of standard operating procedures (SOPs) related to regulatory submissions
• Ensure adherence to regulatory requirements throughout the submission process

Cross-functional Collaboration:

• Work closely with various departments, including R&D, Clinical, Manufacturing, and Quality Assurance
• Facilitate effective communication between internal teams and regulatory authorities
• Participate in project team meetings to provide regulatory input and updates

Documentation Management:

• Maintain accurate and up-to-date regulatory documentation
• Assist in the organization and archiving of regulatory submissions and correspondence
• Contribute to the development and maintenance of regulatory databases

Desired Qualities:

• Proactive and self-motivated with a strong work ethic
• Ability to work effectively in a team environment
• Analytical mindset with strong problem-solving skills
• Adaptable to changing priorities and regulatory landscapes
• Commitment to continuous learning and professional development