Head of Regulatory Affairs For EU & Regulated Markets

V S International

Posted: 3 months ago
Openings: 10
Applicants: 0

Job Description

V.S. International Private Limited (VSI) is a trusted pharmaceutical manufacturer since 1997, delivering high-quality formulations and contract manufacturing to regulated and emerging markets worldwide.

Professional Experience & Expertise

• Extensive experience in EU regulatory submissions
• Proven expertise in lifecycle management, including variations (Type IA/IB/II), renewals, line extensions, and post-approval change management.
• Strong hands-on experience in Bioequivalence (BE) strategy, study management, submissions, and regulatory responses for EU and regulated markets.
• Demonstrated capability in regulatory due diligence, GAP analysis, and dossier readiness for market expansion.
• Experience interacting directly with EMA, RMS/CMS, and national competent authorities for scientific advice, deficiency responses, and regulatory clarifications.
• Leadership experience managing and mentoring regulatory teams, ensuring compliance, quality, and adherence to timelines.

Key Responsibilities

• Lead EU and regulated market regulatory affairs activities across the product lifecycle, from submission to post-approval maintenance.
• Develop and execute EU regulatory strategies aligned with business objectives and market priorities.
• Oversee variation management, renewals, and regulatory compliance activities in line with EU legislation and guidelines.
• Lead Bioequivalence planning and management, including study oversight, dossier integration, and regulatory justification.
• Act as the primary regulatory interface with EU regulatory authorities and internal stakeholders.
• Coordinate cross-functionally with Quality, Manufacturing, R&D, PV, Supply Chain, and Marketing to ensure data availability and compliance.
• Ensure labeling, artwork, pharmacovigilance, and quality agreement compliance for EU and regulated markets.
• Support tender strategies and provide regulatory input to commercial and business development teams.
• Build, train, and develop a high-performing

.Regulatory Affairs team with strong EU expertise.