Snehal Pereira
Manager @Cencora
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WORK HISTORY
Manager @Cencora
IN
Drove continuous improvement initiatives, upskilling self and team through 5+ process enhancements annually, contributing to improved project delivery efficiency and alignment with organizational goals.• Ensured adherence to quality standards, achieving ≥95% SLA compliance, incorporating reviewer feedback, and maintaining 100% quality checklist adherence while consistently meeting project timelines and customer expectations.• Maintained audit readiness, keeping major or critical findings below 5% of total audit observations across client and internal audits.• Ensured 100% on-time closure of CAPAs within defined regulatory and organizational timelines.• Managed 10+ regulatory projects annually, delivering high-quality outcomes with >95% on-time delivery and strong customer satisfaction.• Created, compiled, and validated 50+ electronic submissions (eCTD and NeeS), including MAAs, amendments, variations, and renewals across multiple regions.• Managed the lifecycle of 20+ approved products (electronic submissions only), ensuring regulatory compliance and timely post-approval updates.• Prepared and maintained 10+ SOPs and Work Instructions, supporting internal training and process standardization across teams.• Edited and formatted 100+ regulatory documents in accordance with ICH guidelines, ensuring accurate bookmarks, hyperlinks, and structural consistency.• Actively managed and mentored a 10-member regulatory team, improving collaboration and contributing to on-time execution of 95%+ regulatory activities.• Developed regulatory strategies for EU submissions, supporting successful approvals and reduced regulatory queries.• Led 5–8 small-scale regulatory projects, effectively coordinating tasks, timelines, and deliverables to meet business objectives.
EDUCATION
Institute of Clinical Research(ICRI), Cranfield University
PG Diploma in Clinical Research Management
Institute of clinical research, Cranfield University (UK)
Master of Science (M.Sc.), Clinical research
Wilson College, Mumbai University
Bachelor of Science (BSc), Biotechnology
SKILLS
ABOUT SNEHAL PEREIRA
Seasoned Regulatory Affairs professional with 15+ years of experience delivering high-quality global regulatory submissions and lifecycle management for pharmaceutical products across US, UK, EU, Canada, Australia, New Zealand, ASEAN, and ROW markets.I specialize in electronic regulatory publishing and submission management, with deep expertise in eCTD, NeeS, CTD, and ACTD formats. My experience spans the full submission lifecycle from MAAs and initial filings to variations, amendments, renewals, and post-approval changes ensuring compliance with ICH and Health Authority requirements.Currently serving as Manager – Regulatory Affairs at PharmaLex, I lead and mentor high-performing teams while managing multiple global regulatory projects. I consistently drive ≥95% on-time delivery, maintain audit readiness, and ensure 100% CAPA closure within defined timelines. My focus on process improvement, SOP development, and quality excellence enables efficient, submission-ready outcomes aligned with client and regulatory expectations.I bring hands-on proficiency with regulatory platforms and tools including CESP, EMA ESG Gateway, FDA ESG Gateway, MHRA, Veeva Vault, eCTD Manager, Docubridge, and ISI Toolbox. In addition to technical expertise, I am passionate about team development, cross-functional collaboration, and training, having successfully built and guided teams to deliver consistent, compliant, and high-impact regulatory outputs.Recognized for my ability to translate complex regulatory requirements into actionable strategies, I thrive in fast-paced, global environments and remain committed to enabling timely Health Authority approvals through precision, quality, and leadership.#RegulatoryAffairs #RegulatoryPublishing #eCTD #GlobalSubmissions #LifecycleManagement#ICHCompliance #PharmaceuticalRegulatory #EURegulatory #FDA #EMA #VeevaVault #RegulatoryLeadership #QualityCompliance #AuditReadiness #CAPAManagement
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