Consultant / Sr. Consultant – Regulatory Affairs, Pharmacovigilance & Market Research
Budget: ₹500,000 – ₹1,000,000 INR
The assignment is split roughly 70 % regulatory affairs work and 30 % primary market research. On the regulatory side, the consultant will prepare, review, and file complete eCTD-ready dossiers, maintain all compliance records, and keep every submission on schedule. Coordination is required with three health authorities—CDSCO, FDA, and EMA—for new registrations, renewals, and full lifecycle management, so proven experience interacting with each of those agencies is essential.
Pharmacovigilance support is also in scope: continuous safety reporting, post-marketing compliance activities, and development of proactive risk-management measures must run in parallel with the regulatory programme.
Primary market research will involve planning and conducting stakeholder interviews, analysing feedback, and distilling clear commercial and clinical insights that can be fed back to cross-functional teams.
Deliverables
• Accepted submissions (registrations, renewals, lifecycle updates) with formal acknowledgement from CDSCO, FDA, and EMA
• Up-to-date trackers, SOP-compliant PV reports, and risk-management documentation
• A concise insight report from the market-research phase, highlighting key opportunities and threats
A degree in Pharmacy or Life Sciences and 5–8 years of hands-on regulatory and PV work are mandatory. Familiarity with ICH guidelines, current FDA/EMA/Indian regulations, and standard market-research techniques will be evaluated during selection.
Pharmacovigilance support is also in scope: continuous safety reporting, post-marketing compliance activities, and development of proactive risk-management measures must run in parallel with the regulatory programme.
Primary market research will involve planning and conducting stakeholder interviews, analysing feedback, and distilling clear commercial and clinical insights that can be fed back to cross-functional teams.
Deliverables
• Accepted submissions (registrations, renewals, lifecycle updates) with formal acknowledgement from CDSCO, FDA, and EMA
• Up-to-date trackers, SOP-compliant PV reports, and risk-management documentation
• A concise insight report from the market-research phase, highlighting key opportunities and threats
A degree in Pharmacy or Life Sciences and 5–8 years of hands-on regulatory and PV work are mandatory. Familiarity with ICH guidelines, current FDA/EMA/Indian regulations, and standard market-research techniques will be evaluated during selection.