Aodh Lifesciences
Website:
aodhlifesciences.in
Job details:
Company Description
Aodh Lifesciences is a deep science innovation platform focused on developing advanced treatments for acute and chronic respiratory tract infections, which significantly impact patients' quality of life. The company has expertise in nasal and inhalation-targeted drug development, including Pharmacokinetic-Pharmacodynamic (PKPD) analysis, Physiologically Based Pharmacokinetic (PBPK) modeling, and Nasal & Inhalation In Vitro-In Vivo Correlation (IVIVC) studies. At Aodh Lifesciences, we are dedicated to delivering groundbreaking solutions through rigorous research and specialized knowledge.
Role Description
The Regulatory Affairs Associate will be responsible for preparing, reviewing, and managing regulatory documentation to support product approvals and compliance. They will ensure all processes adhere to regulatory requirements and assist in preparing regulatory submissions. Additional duties include keeping up-to-date with regulatory guidelines and providing support to the team in meeting compliance goals. This is a full-time, on-site role located in Hyderabad.
Key Responsibilities
• Support preparation and maintenance of CTD Modules (2–4)
• Assist in building Claims → Evidence maps and traceability systems
• Review study reports for protocol compliance and data completeness
• Support data integrity checks (ALCOA+, raw data tracking, documentation)
• Coordinate with internal teams and vendors for dossier-ready outputs
• Help maintain regulatory requirements matrices and decision logs
• Assist in submission readiness tracking and documentation QC
Qualifications
- 2–3 years of experience in Regulatory Affairs
- Experience in maintaining CTD structure (Modules 1–5)
- Proficiency in Regulatory Documentation for submission and compliance processes
- Knowledge of Regulatory Compliance and Regulatory Requirements to ensure adherence to guidelines
- Experience or training in Regulatory Submissions and Regulatory Affairs practices
- Strong organizational, communication, and interpersonal skills
- Detail-oriented with a commitment to high-quality work
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field
📩 Freshers with relevant training are encouraged to apply.
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