Nishtha Kulshreshtha

Highly accomplished Global Regulatory Affairs Professional with 19+ years of experience leading complex international pharmaceutical submissions, lifecycle management, regulatory strategy, and technical dossier operations across regulated and semi-regulated markets. Extensive expertise in European Regulatory Procedures (MRP/DCP/National), Generic, Hybrid & WEU Applications, CTD/eCTD Technical Dossier Management, Global Lifecycle Management, CMC Regulatory Strategy, Regulatory Operations & Compliance Governance, and Global Health Authority Interactions. Demonstrated success managing geographically distributed teams, multinational CMO networks, and remote cross-functional regulatory operations supporting global product registrations and commercial launches.

Recognized for delivering technically robust submissions, accelerating approvals, resolving complex deficiencies, and establishing scalable regulatory systems aligned with international regulatory expectations.

Head – Global Regulatory Affairs - PRIME PHARMACEUTICALS LTD. - Mumbai, India

(2024-01)

Leading Global Regulatory Affairs operations for Europe, UK, ANZ, Canada, APAC, LATAM, ASEAN, CIS, MEENA, and ROW markets.

• Define and execute global regulatory strategies for Generic, Hybrid, and WEU submissions
• Lead technical dossier preparation, review, and submission for EU and ROW markets.
• Oversee CTD/eCTD lifecycle management activities including Variations, Renewals, Line Extensions, and Artwork updates
• Review and approve technical CMC documentation including Stability data, Specifications, Validation summaries, and Development reports
• Coordinate regulatory activities with 50+ CMOs and API manufacturers globally.
• Lead deficiency response management and scientific justifications for health authorities.
• Drive regulatory compliance systems, SOP frameworks, and submission governance.
• Mentor and manage regulatory teams operating across multiple product portfolios.
• Experience on global Client handling.
• Strengthened EU regulatory strategy framework
• Improved dossier quality and approval timelines
• Enhanced remote regulatory coordination with international partners
• Streamlined lifecycle management and submission tracking systems

Senior Manager & Head – Regulatory Affairs - NEON LABORATORIES LTD. - Mumbai, India

(2022-07 - 2023-12)

• Managed global ROW submissions aligned with SRA dossier expectations.
• Led preparation and review of CTD/ACTD dossiers and lifecycle submissions.
• Reviewed CMC documentation, Labeling, Artwork, Stability reports, and Validation data
• Coordinated scientific responses to authority deficiencies and technical queries.
• Managed API regulatory documentation including DMFs, CEPs, and GMP compliance.
• Developed standardized templates and SOPs to improve regulatory consistency.
• Reduced regulatory deficiencies through enhanced technical review
• Improved submission quality and compliance controls
• Strengthened global dossier harmonization practices

Senior Manager - IPCA LABORATORIES LTD. - Mumbai, India

(2007-03 - 2022-07)

• Supported global submissions and arranging technical documents for dossier preparation.
• Prepared and reviewed Product Development Reports, CMC documentation, Technical justifications, and Stability summaries
• Coordinated with cross-functional teams for dossier readiness and regulatory compliance.
• Supported process optimization and data integrity initiatives.
• Conducted internal training on regulatory documentation standards.
• Supported successful approvals
• Enhanced technical documentation quality
• Improved regulatory compliance awareness across functions

Officer – Quality Control - MEDERICH PHARMA - Bangalore, India

(2005 - 2007)

• Conducted analytical and microbiological testing under GMP environment.
• Supported QC documentation and compliance activities.

Ph.D. - Biotechnology - D. Y. Patil University Navi Mumbai

Diploma - Regulatory Affairs - GIRA Pune

M.Sc. - Biotechnology - Jiwaji University Gwalior

B.Sc. - CBZ - Jiwaji University Gwalior