Regulatory Affairs Job at Aodh Lifesciences | Biotechnology & Life Sciences | Apply Now
Aodh Lifesciences is looking for a meticulous Regulatory Affairs Associate to join its team in the pharmaceutical hub of Hyderabad. This Regulatory Affairs Job is an ideal growth opportunity for professionals with at least one year of experience who are eager to master the complexities of global dossier submissions. You will play a vital role in ensuring that scientific data is translated into “submission-ready” documentation, focusing on the Common Technical Document (CTD) framework and rigorous data integrity standards. For those pursuing a Life Sciences Job, this onsite position offers a structured path into high-level regulatory strategy and compliance management.
About the Company
Aodh Lifesciences is a dynamic healthcare and life sciences organization based in Hyderabad, specializing in the development and regulatory lifecycle management of pharmaceutical products. Moreover, jobs in regulatory affairs have become essential for companies committed to bridging the gap between innovative research and market approval by maintaining the highest standards of documentation and data integrity. Operating in a fast-paced, detail-oriented environment, Aodh Lifesciences prides itself on a culture of continuous learning and operational discipline. By collaborating with both internal R&D teams and external vendors, the organization ensures that every medical claim is backed by ironclad evidence, ultimately accelerating the delivery of safe and effective treatments to patients.
Key Responsibilities
In this Regulatory Affairs Job, your daily tasks will revolve around the “Technical” in Common Technical Document.
- CTD Maintenance: Support the preparation and maintenance of Modules 2–4 (Summaries, Nonclinical, and Clinical reports) of the CTD, which is a crucial element for candidates seeking a regulatory affairs job.
- Traceability Systems: Assist in building Claims → Evidence maps, ensuring that every clinical claim in a submission is linked to verified raw data.
- Data Integrity (ALCOA+): Support rigorous integrity checks based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more) to ensure documentation practices meet global audit standards.
- Report Review: Review study reports for protocol compliance and data completeness, acting as a final line of Quality Control (QC) before submission. This process provides a deeper understanding for those advancing in regulatory affairs jobs.
- Dossier Coordination: Coordinate with internal teams and external vendors to ensure all outputs are “dossier-ready” and adhere to strictly defined timelines.
- Decision Logs: Maintain regulatory requirements matrices and decision logs to track submission readiness across multiple projects, which is essential for regulatory affairs job responsibilities.
Qualifications and Requirements
Aodh Lifesciences is seeking a candidate who combines scientific literacy with extreme attention to detail. In this regulatory affairs job, these qualities are vital for success.
- Education: Bachelor’s or Master’s degree in Life Sciences or Biotechnology.
- Experience: 1+ Years of relevant work experience; a minimum of 1 year of formal training in Regulatory Affairs is highly preferred. This regulatory affairs job also values hands-on training and practical knowledge.
- Technical Literacy: Foundational understanding of the CTD structure (Modules 1–5) and familiarity with CMC (Chemistry, Manufacturing, and Controls) documentation concepts.
- Tools: Exposure to Document Management Systems (like SharePoint) and basic Excel skills for tracking regulatory matrices.
- Attributes: Strong documentation discipline, excellent communication skills, and a proactive “willingness to learn” mindset. A combination of these soft skills and technical knowledge is what makes regulatory affairs jobs rewarding.
Salary & Location Details
- Salary: ₹3–5 LPA (depending on experience and interview performance).
- Location: Hyderabad, India (Full-time, On-site). If you are seeking an on-site role and searching for regulatory affairs jobs in Hyderabad, this may be your next professional step.
In summary, the Regulatory Affairs Associate role at Aodh Lifesciences is a definitive Regulatory Affairs Job for those ready to move from basic data entry to strategic submission management. This Life Sciences Job places you at the intersection of science and law, where your ability to maintain ALCOA+ standards directly impacts a drug’s path to market. Because the role involves “Claims → Evidence mapping,” your success will depend on your ability to synthesize complex clinical data into clear, compliant summaries. If you are a detail-oriented professional looking to grow in a structured Hyderabad-based environment, Aodh Lifesciences offers the perfect platform for your regulatory affairs career.
