Job Description
Designation: Regulatory Affairs Specialist
Location: Hyderabad (On-site)
At Aodh Lifesciences, we are building a next-generation deep science drug development company focused on redefining respiratory drug delivery through a regulatory-driven approach. Our work integrates translational biology, microbiology, advanced formulation and device engineering, PBPK modelling, IVIVC modelling, and regulatory-grade data generation to develop targeted therapies designed to improve local efficacy while minimizing systemic exposure and addressing antimicrobial resistance.
We are looking for driven individuals who are curious, think deeply about the science, and are excited to take ownership in a zero-to-one environment, building not just products but a globally relevant, regulatory-grade R&D ecosystem from the ground up.
Role Summary
The Regulatory Specialist coordinates regulatory documentation, owning the end-to-end process of converting sourced data into compliant regulatory narrative documents. It coordinates the authoring workflow, manages documentation quality, and ensures every deliverable is correctly formatted, aligned, and submission-ready. As and when required, deficiency has to be addressed based on regulatory responses.
Key Responsibilities
Act as the single point of contact between the department (the authors) and the regulatory documentation pipeline.
Issue authoring assignments to the appropriate departments based on document type and scope.
Ensure timelines are met.
Maintain a tracking system (assignments, due dates, revision cycles, sign-off status).
Escalate delays, gaps, or ambiguities in scope to the reporting manager/CEO in a timely manner.
Collate compile & analyse source data & author into CTD granularity
Ensure each authored narrative complies with applicable regulatory standards (ICH, CDSCO, FDA, EMA, as applicable)
Ensure narrative documents accurately reflect the underlying signed source content without introducing interpretive changes.
Review the regulatory readiness of the submission documents received from different stakeholders.
Maintain complete traceability of all documentation.
Follow ALCOA+ guidelines and maintain document lifecycle.
Apply QA principles to verify completeness, accuracy, and regulatory compliance of all documents.
Conduct QC checks: cross-reference verification, data consistency between source and narrative, citation accuracy, and adherence to templates.
Ensure documents comply with applicable regulatory frameworks and internal SOPs.
Coordinate with department consultants, subject matter experts, QA, and Regulatory Affairs leadership during review and approval cycles.
Consolidate review comments, route them to the appropriate authors, and verify resolution before finalization.
Facilitate and conduct Management Review Meeting (MRM)
Qualification: 1 - 3 years experience in quality assurance, Freshers with relevant knowledge can also apply.Location
Kukatpally, Hyderabad, Telangana, India 500072