Regulatory Strategy: Developing strategies for new product registrations and lifecycle management.
Submissions: Preparing, compiling, and submitting regulatory documents (e.g., CTD, IMPD) for clinical trials and marketing authorization.
Compliance: Ensuring adherence to changing national and international laws and guidelines (FDA, EMA, MHRA).
Lifecycle Management: Managing variations, renewals, and pharmacovigilance (PSURs).
Labelling & Promotion: Reviewing and approving product labels, patient leaflets, and marketing materials.
Cross-functional Collaboration: Working with R&D, Medical Affairs, Quality, and Marketing teams.
A Pharmaceutical Regulatory Affairs (JD) involves ensuring new and existing drugs meet global laws, from development (clinical trials, data compilation) to market (labelling, marketing approval) and post-market (safety reporting), by preparing submissions (IMPDs, SmPCs), liaising with agencies (FDA, EMA), and advising senior management on compliance, requiring strong scientific, legal, and communication skills.
Job Type: Full-time
Pay: ₹12,000.00 - ₹20,000.00 per month
Work Location: In person
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