Experience:

10–11 years in Regulatory Affairs (preferably in Pharma, Biotech, or Healthcare)

Role Overview:

The Regulatory Head will lead global regulatory strategies and oversee product registrations across multiple international markets. This role ensures compliance with global regulatory requirements and drives timely approvals to support business expansion worldwide.

Key Responsibilities:
Global Regulatory Strategy
Develop and implement regulatory strategies for product approvals in key markets (US, EU, ROW, emerging markets)
Provide regulatory guidance during product development and lifecycle management
Align regulatory plans with business goals and launch timelines
Worldwide Product Registration
Manage end-to-end registration processes across international markets
Oversee preparation, review, and submission of dossiers (CTD/eCTD formats)
Ensure timely approvals, renewals, and variations
Regulatory Compliance
Ensure compliance with global regulatory authorities (e.g., FDA, EMA, MHRA, WHO, etc.)
Monitor changes in global regulatory requirements and implement updates




Handle regulatory inspections, audits, and queries
Team Leadership & Stakeholder Management
Lead and mentor the regulatory affairs team
Collaborate with cross-functional teams (R&D;, QA, Manufacturing, Marketing)
Act as the key point of contact with regulatory agencies and partners
Documentation & Submission Management
Review technical documents including dossiers, DMFs, ANDAs, MAAs
Ensure high-quality submissions meeting country-specific requirements
Manage regulatory databases and documentation systems
Risk Management
Identify regulatory risks and develop mitigation strategies
Ensure proactive resolution of deficiencies and queries

Required Qualifications:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
Advanced certifications in Regulatory Affairs (preferred)

Pay: From ₹1,500,000.00 per year

Perks:
Cell phone reimbursement
Provident Fund

Work Location: In person

📌 Regulatory Affairs – Worldwide Registration Thane
🏢 Vitane Pharmaceuticals
📍 Thane