🚀 We’re Hiring: Regulatory Affairs Specialist 🚀
Location: Hyderabad for one of the prestigious pharma company
Are you a regulatory expert looking to make a real impact? Do you have experience working with DCGI and CDSCO? We are on the lookout for a Regulatory Affairs Specialist who’s passionate about compliance and ready to help drive our success. If you’re someone who thrives on solving challenges, building relationships, and making sure everything is up to code, keep reading!
What You’ll Do:
🔑 Regulatory Documentation:
Your role is crucial in preparing, submitting, and ensuring the success of all regulatory filings. You’ll be working directly with DCGI and CDSCO to get approvals, maintain licenses, and keep us compliant with the latest regulations.
💬 Liaison with Authorities:
You’ll be the key point of contact for DCGI, CDSCO, and other regulatory bodies. You’ll manage relationships, answer queries, and ensure we stay ahead of any regulatory hurdles.
📋 Compliance at the Core:
Your job will be to monitor and enforce compliance with all local regulations. You’ll keep us updated on any changes in the regulatory environment and help implement any necessary adjustments internally.
📂 Managing Documents:
Keeping accurate records is essential. You’ll ensure all regulatory filings, licenses, and approvals are tracked and maintained in an organized manner, so nothing slips through the cracks.
🤝 Supporting Teams:
You’ll partner with R&D and QA to ensure that our products meet regulatory standards. Your expertise will be critical as we move products from development through to market.
🔍 Prepare for Inspections & Audits:
You’ll coordinate all aspects of regulatory inspections and audits, ensuring that everything is ready when authorities arrive. You’ll help resolve any issues or findings quickly and effectively.
📚 Training & Education:
You’ll be an internal resource, conducting training sessions to make sure everyone is aligned with current regulatory requirements and best practices.
What You Need to Succeed:
🎓 Education: A degree in Pharmacy, Life Sciences, or a related field. A Master’s degree is a plus!
📅 Experience:
5+ years of experience in regulatory affairs with strong knowledge of DCGI/CDSCO guidelines and compliance requirements.
🔍 Regulatory Knowledge: You’re an expert in the Indian regulatory landscape and understand local rules, guidelines, and timelines.
🗣 Communication Skills: You have excellent communication skills, able to build strong relationships with regulatory authorities and cross-functional teams.
🧩 Problem Solver: You enjoy finding solutions and tackling regulatory challenges with ease.
Ganesh Naidu Janne
Note : only immediate joiners or 30 days notice period candidates apply
send resume@ 9866719940 only whatsapp or greenika.sinara@gmail.com
