Looking for a job

Sakshi Mandaliya

@sakshimandaliya

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I support FDA submissions, regulatory intelligence, and GMP compliance improvements.

United States

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What I'm looking for

I'm looking to contribute to regulatory submissions, regulatory intelligence, and quality compliance work while growing in FDA and global regulatory strategy.

I've supported FDA and global regulatory submissions at Apellis Pharma (Biogen), managing regulatory records in Veeva Vault/EDMS and improving RIM workflow traceability.

At Culture Care Collective, I built a Python-based preprocessing algorithm that improved patient–CHW connection accuracy by 18% and trained an LLM on healthcare data to accelerate issue resolution and access by 24%.

I've also strengthened regulatory intelligence and quality systems: at Global Med Regs, I improved compliance efficiency by 25% through a centralized database, while at Suryen Pharma I supported GMP documentation, CAPA investigations, and audit readiness.

I'm pursuing an MS in Regulatory Affairs at Northeastern and hold a patent for an optimized herbal anti-inflammatory balm stick, with a roadmap for future IND submission.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Intern

Apellis Pharmaceuticals

Apr 2026 - Sep 2026 (5 months)

Supported FDA and global regulatory submission activities through effective tracking and management of regulatory records in Veeva Vault/EDMS. Collaborated with GRO teams to streamline submission workflows and enhance data governance.

Veeva Vault EDMS RIM Regulatory Submissions Data Integrity Cross Functional Collaboration

Experiential Project Regulatory Affairs Intern

Culture Care Collective

Jan 2025 - Apr 2025 (3 months)

Boosted patient–CHW connection accuracy by 18% using a Python-based preprocessing algorithm. Trained an LLM on healthcare data, accelerating issue resolution and access for underserved patients by 24%.

Python LLM Healthcare Data data preprocessing Workflow Optimization

Regulatory Research Executive

Global Med Regs

Sep 2024 - Dec 2024 (3 months)

Improved compliance efficiency by 25% through a centralized regulatory intelligence database. Analyzed 4 global regulatory frameworks to identify overlaps and gaps to support strategic harmonization.

Regulatory Intelligence Regulatory Frameworks Compliance Data Analysis Harmonization

Quality Assurance Intern

Suryen Pharma

Jan 2023 - Aug 2023 (7 months)

Reviewed SOPs, batch records, and quality documents to ensure full GMP compliance. Assisted in CAPA investigations, reducing recurring compliance issues by 24% and streamlining workflows.

GMP SOP Review CAPA Internal Audit Data Analysis Quality and Compliance

Education

Degrees, certifications, and relevant coursework

Northeastern University

Master of Science, Regulatory Affairs

Pursuing a Master of Science in Regulatory Affairs with expected graduation in December 2026. Coursework includes FDA Pharmaceutical Regulation, Regulatory Strategy, Drug Development, Safety Sciences, Quality Assurance, Pharmacovigilance, Product Lifecycle Management, and Clinical Trials.