Consultant / Sr. Consultant – Regulatory Affairs, Pharmacovigilance & Market Research

₹500000-1000000 INR

Closed

Posted 7 days ago

₹500000-1000000 INR

Paid on delivery

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.

Project ID: 40534008

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2 freelancers are bidding on average ₹700,000 INR for this job

@borisevichvolga

With more than two decades of successfully launching and managing complex international projects, I am confident in my ability to excel as your Regulatory Affairs and Market Research consultant. My career spans across Europe, China, India, ASEAN and CIS markets - regions which are deeply related to your project in terms of regulations, markets, and authorities. I have navigated myriad health authorities within these regions and have a firm grasp of current FDA/EMA/Indian regulations to ensure your submissions are always on point and on schedule. In addition to my robust knowledge of international trade and supply chain management, I possess an in-depth understanding of compliance, risk management and documentation - all skills which are paramount for this project. My experience with KYC/AML & Regulatory Compliance will prove invaluable when coordinating with CDSCO, FDA, and EMA for registrations, renewals, and full lifecycle management. Lastly, my ability to leverage quantitative information into concise commercial insights aligns perfectly with the market research component of your project. Combining the data-driven approach with my skill in distillation and market insight analysis, I can deliver a report that not only highlights key opportunities and threats but also actionable strategies for your cross-functional teams.

₹650,000 INR in 7 days