Key Accountabilities:

Submission Coordination:

Assist in the preparation and coordination of regulatory submissions, including:Investigational New Drug (IND) applicationsInvestigational Medicinal Product Dossiers (IMPDs)Post-approval commitmentsAnnual reportsResponses to regulatory authority questionsEnsure all submissions are complete, accurate, and compliant with regulatory requirementsManage submission timelines and coordinate with cross-functional teams to gather necessary documentation

Regulatory Assessment Support:

Support the team in conducting regulatory assessments of manufacturing changesAnalyze the potential impact of manufacturing changes on regulatory complianceAssist in preparing documentation to support manufacturing change assessments

Regulatory Compliance:

Stay current with relevant regulations and guidelinesContribute to the development and maintenance of standard operating procedures (SOPs) related to regulatory submissionsEnsure adherence to regulatory requirements throughout the submission process

Cross-functional Collaboration:

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

Documentation Management:

Maintain accurate and up-to-date regulatory documentationAssist in the organization and archiving of regulatory submissions and correspondenceContribute to the development and maintenance of regulatory databases

Desired Qualities:

Proactive and self-motivated with a strong work ethicAbility to work effectively in a team environmentAnalytical mindset with strong problem-solving skillsAdaptable to changing priorities and regulatory landscapesCommitment to continuous learning and professional development