Addictive Media
Website:
theaddictivemedia.com
Job details:
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, on-site (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
Click on Apply to know more.
