Head of Regulatory Affairs (Delhi)

Head of Regulatory Affairs (Delhi)

31 Jul
|
Addictive Media
|
Delhi

31 Jul

Addictive Media

Delhi

Job Title: Head of Regulatory Affairs — Pharma Export (WHO-GMP / CDSCO) Location: Faridabad (Delhi NCR) — office is a 3-minute walk from Mohan Co-operative Metro Station (Violet Line) Experience: 7–10+ years Employment Type: Full-time, in office (this role requires regular in-person coordination with CDSCO and cannot be remote)

The Role

We're hiring a Head of Regulatory Affairs to own end-to-end export drug registration strategy — from CDSCO relationship management to COPP/CTD dossier sign-off across 15+ active and target markets. You'll build and lead the regulatory team from scratch, set the process, and be the final check before anything goes out the door. This is a high-ownership role. You're not executing someone else's playbook — you're writing it.

What You'll Own

CDSCO liaison for WHO-GMP certification, COPP applications, and export NOCs

Country-by-country registration strategy across Africa, Middle East, CIS, and South-East Asia

Final review and sign-off on every CTD/ACTD dossier before submission

Building and managing a regulatory team (Managers, Executives, Coordinators) as the company scales





Coordinating with QA/QC and plant leadership to ensure stability data, batch records, and COAs are submission-ready

Pre-empting regulatory queries before they cost a resubmission cycle

What You Bring

7–10+ years in pharmaceutical regulatory affairs, with hands-on export dossier experience (not domestic-only)

Direct experience with CDSCO processes — WHO-GMP certification, COPP, export documentation

CTD/ACTD dossier compilation and submission experience across at least 2-3 international markets

Comfort building a team and process from scratch, not just operating inside an existing one

Based in or willing to relocate to Delhi NCR

Why This Role

Ground-floor opportunity to build a regulatory function from zero at a fast-growing WHO-GMP manufacturer

Direct reporting line to leadership — your calls on strategy and hiring carry real weight

Office location: 3-minute walk from Mohan Co-operative Metro Station — no last-mile commute pain

📌 Head of Regulatory Affairs (Delhi)
🏢 Addictive Media
📍 Delhi

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