Greetings from 3GHR Services!!

We are hiring a "Regulatory Affairs AI Specialist."

Regulatory Affairs AI Specialist

AI-native regulatory documentation & eCTD submission automation for life sciences

LOCATION
Hyderabad—travel to customer sites

EXPERIENCE
5–10+ years in regulatory affairs

FUNCTION
Regulatory Affairs × AI

ROLE OVERVIEW

We are looking for a hands-on regulatory affairs professional to help shape and validate an AI-driven dossier authoring, review, and submission platform. You will bring deep, practical experience across US and EU filings together with a working command of AI tools, partnering closely with our product and engineering teams to ensure generated content meets health-authority expectations.

KEY RESPONSIBILITIES

- Understand customer data and dossier requirements.
- Configure the AI platform to meet specific customer requirements.
- Own the creation of templates and AI-driven generation of dossiers across dosage forms for US, EU, ACTD, and other markets.




- Review generated dossiers against applicable regulatory requirements.

MUST HAVE

1. First-time filing experience: hands-on authoring, review, and submissions for initial filings in the US and EU (e.g., IND, ANDA, NDA, BLA, MAA).
2. Health authority queries: hands-on management, including data gathering and drafting of responses.
3. Source data review: hands-on review of source data from R&D;, manufacturing, and related functions.
4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.
5. AI fluency: practical understanding and hands-on experience using AI tools in a professional setting.

POSITIVE TO HAVE

- Rest-of-World (RoW) submission experience, including ACTD, GCC, and CIS/Russia regions.

Pay: ₹500,000.00 - ₹1,800,000.00 per year

Work Location: In person

📌 Regulatory Affairs (Hyderabad)
🏢 Intellica Logic
📍 Hyderabad