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:
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
Benefits:
- Cell phone reimbursement
- Provident Fund
Work Location: In person
