Senior Regulatory Affairs Executive

Contract research clients send us samples from trial sites all over the world. Clinical programs include two antibody candidates in Phase II for autoimmune disease. Gowning for cleanroom work takes about 15 minutes each time.

We need a Senior Regulatory Affairs Executive. This is a full-time position based in Hyderabad, Telangana. This position focuses on CMC sections for IND amendments and an upcoming NDA. Our Regulatory Operations team supports drug products in clinical trials across the US, EU and Canada. Hybrid. You will need to be in Hyderabad at least two days per week.

Essential duties and responsibilities

Keep regulatory files and correspondence organised and inspection ready. Coordinate with international distributors on country registrations. Review labeling, IFUs and promotional materials for regulatory compliance and supported claims. Build regulatory strategy memos for new products and line extensions. File MDRs and support complaint and recall decisions with quality.

Required qualifications

5+ years of regulatory affairs experience in medical devices, pharma or biologics. Able to travel up to 10 percent. Familiarity with eCTD structure and submission publishing tools. Clear technical writing and careful editing. Comfortable managing several submissions and deadlines at once. Bachelor's degree in a life science, engineering or pharmacy.

Nice to have

Master's degree or PharmD. Software as a medical device (SaMD) and cybersecurity submissions.

Schedule: Hybrid, two days on site per week

Why work with us

Salary: ₹12,50,000 - ₹15,00,000 per annum

Health insurance for you and your family. Provident fund. Paid leave. Flexible hours. Gratuity. Learning budget.

Candidates must be eligible to work in India.

Start: Within 30 days.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Chauhan Life Sciences.