Greetings from 3GHR Services!!

We are hiring "Regulatory Affairs AI Specialist."

Qualification: Graduation

Experience: 5+Years

Salary: For 5-8 Yrs of experience (based on last CTC)

10+ Years (15-25 LPA)

Work Mode: Hybrid

Industry: Pharmaceutical / Life Sciences

Function: Regulatory Affairs / Regulatory Consulting

Location: Hyderabad

Travel: Willingness to travel to customer locations

Key Responsibilities

- Understand customer data, regulatory requirements, and dossier requirements.
- Configure AI platforms based on specific customer and regulatory requirements.
- Create and review regulatory dossier templates and AI-generated content.
- Prepare and review dossiers across different dosage forms and markets.
- Support US, EU, ACTD, and other regulatory submissions.
- Review AI-generated dossiers against applicable regulatory guidelines.
- Manage Health Authority queries, including data gathering and preparation of responses.
- Review source data from R&D;, manufacturing, quality, and other cross-functional teams.
- Handle post-approval lifecycle management activities for US and EU markets.




- Train customers on AI-powered dossier generation and regulatory review.
- Collaborate with product and engineering teams to improve AI-driven regulatory workflows.

Mandatory Skills

- 5-12+ years of hands-on regulatory affairs experience
- Hands-on experience in initial US and EU filings
- Experience with filings such as IND, ANDA, NDA, BLA, MAA
- Experience in Health Authority query management and response preparation
- Experience reviewing source data from R&D;, Manufacturing and related functions
- Hands-on experience in post-approval / lifecycle management
- Practical AI tools / Generative AI experience in a professional workplace
- Strong understanding of regulatory dossier authoring, review, and submission

Good to Have

- ACTD submission experience
- Rest-of-World (RoW) regulatory experience
- GCC / CIS / Russia regulatory submissions
- Experience across multiple dosage forms
- Regulatory consulting experience

Contact: (phone hidden) [email protected]

📌 Regulatory Affairs | 5-12 Yrs | US & EU filings | Hybrid For Snr | Hyd (Hyderabad)
🏢 3G HR Services
📍 Hyderabad