**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 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.