Key Responsibilities
- Compile and submit CTD/ACTD dossiers for export markets across Africa, South-East Asia, LATAM and CIS.
- Manage the full registration lifecycle — queries, deficiency responses, approvals, renewals and variations — with a live country-wise tracker.
- Handle CoPP, WHO-GMP Certificate, Free Sale and Market Standing Certificates with CDSCO and MP State FDA, including notarisation, apostille and embassy legalisation. Prepare the regulatory and technical sections of international and domestic tender bids for UN agencies, government health departments and NGOs.
- Maintain Site Master File, product specifications, stability data and change control documentation in line with WHO GMP and Schedule M.
- Approve artwork, labels and pack inserts as per destination-country regulations. Support regulatory, buyer and third-party audits.
- Track regulatory changes in target markets and flag current registration opportunities
- Candidate Requirements-
- M.Pharm preferred; B.Pharm or M.Sc (Chemistry or Microbiology) also considered.
- 4–8 years in regulatory affairs with an export-oriented formulation manufacturer; semi-regulated market experience essential.
- Hands-on CTD/ACTD dossier compilation and deficiency response drafting. Working knowledge of WHO GMP, Schedule M and ICH stability requirements.
- Strong technical English writing; able to correspond directly with foreign health authorities and overseas distributors.
- Disciplined with version control, trackers and deadlines; proactive in follow-up.
- What We Offer-
- Direct reporting to the COO with genuine ownership of the regulatory function. Exposure to global tenders and international health organisations.
- Compensation in line with experience and industry standards.
- To apply, send your CV to
[email protected] with the subject line “RA — Export
Pay: ₹20,000.00 - ₹25,000.00 per month
Benefits
- Cell phone reimbursement
- Paid sick time
- Paid time off
Work Location: In person
📌 Regulatory Affairs Executive (Bhopal)
🏢 HIND PHARMA
📍 Bhopal