Hire Niraj

Niraj Singh

Associate Manager – Global Regulatory CMC

Associate Manager – Global Regulatory CMC with 11+ years of experience in regulatory strategy, CMC authorship, and lifecycle management for global markets (US, EU, and ROW). Skilled in preparing and reviewing CMC documentation (Modules 2 & 3), ANDA/NDA submissions, variations, and deficiency responses. Adept at leading cross-functional collaboration across R&D, Quality, and Manufacturing to ensure timely submissions and regulatory compliance. Strong expertise in change control evaluation, global regulatory intelligence, and strategic planning using RIMS tools (Veeva Vault, TrackWise, EtQ Symphony, Doris, CEDMS). Recognized for driving regulatory efficiencies, delivering first-cycle approvals, and managing product ownership throughout the lifecycle.

FORMERLY AT

ClinChoice

LOCATION

Horsham, Pennsylvania

AVAILABILITY

Full-time

Skills

CEDMS

Document/Submission Repositories (CEDMS)

Doris

EtQ Symphony

MS Office

Project/Tracker Tools

TrackWise

Veeva Vault

Veeva Vault (RIMS)

Work Experience

Associate Manager – Global Regulatory CMC

ClinChoice

Feb 2025 – Present

• Lead CMC lifecycle activities for EMEA region including variations, HA queries, and market rollouts.
• Review, assess, and track global change controls to closure.
• Develop and execute regulatory strategies aligned with project and commercial priorities.
• Act as Regulatory Project Manager, ensuring quality submissions and on-time delivery.
• Maintain submission trackers, monitor timelines, and mitigate potential risks.

TECHNOLOGIES

Veeva Vault (RIMS), TrackWise, EtQ Symphony, Doris, CEDMS, MS Office

Deputy Manager – Global Regulatory CMC

Freyr Solutions

Jul 2023 – Jan 2025

Managed CMC compilation/review for NDA, ANDA, and post-approval submissions.
Assessed change controls, coordinated with global stakeholders, and supported deviation investigations.
Prepared deficiency responses and monitored regulatory updates for risk/impact.

TECHNOLOGIES

Veeva Vault, TrackWise, CEDMS, Doris, MS Office

Lead Consultant – Global Regulatory Affairs

Genpact India Pvt. Ltd.

Aug 2022 – Jun 2023

Authored CMC modules and pharma/food dossiers for global markets.
Performed gap analysis, deficiency response preparation, and regulatory impact assessments.
Partnered with clients/authorities to resolve compliance issues efficiently.

TECHNOLOGIES

Veeva Vault, Document/Submission Repositories (CEDMS), Project/Tracker Tools, MS Office