Regulatory Operations Specialist II

About the role

The Regulatory Operations Specialist II at Fortrea is responsible for creating, revising, compiling, and approving specifications and regulatory documents for client submissions to US, EU, Japan, and ROW health authorities, while overseeing post-approval lifecycle maintenance. Day-to-day work includes preparing CMC and quality documents, managing change control and OOS/OOT investigations, supporting global labeling and stability evaluations, handling import/export licenses, and mentoring junior staff. The role is based in Mumbai and operates on a remote work model with travel required as business needs dictate.

What you’ll do

• Prepare, compile and review product quality (CMC) and other regulatory documents to support product development or submissions to various countries for product registrations or post approval life cycl
• Create/revise/approve raw material and packaging specifications and other associated documents
• Coordinate with cross functional teams for evaluation/impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other p
• Support financial data management, business plan file creation and maintenance, supplier data management and PO creation as required
• Support creation and update of global labeling documents, its content and format, QC and other associated activities for labeling projects
• Support stability data evaluation and report preparation, dissolution profile evaluation etc.
• Perform literature search and preparation of various regulatory documents in support of excipients, APIs and/or drug products
• Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external departments

What you’ll bring

• Bachelor's in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with 4-7 years of experience
• Bachelor's degree from Engineering/B.Tech/Packaging/Polymer/Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field
• At least 4-7 years of experience in the job discipline (e.g., Regulatory Affairs/Quality Assurance/Analytical science/Packaging/polymer and/or printing/pharmaceutics/material management and overall dr
• Technical proficiency with Microsoft Office suite of applications and/or Document Management and/or publishing tools
• Speaking English and/or other languages as applicable
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines
• Good organizational and time management ability
• Good analytical capabilities and customer focus

Nice to have

• Knowledge of Management Information System (MIS) and electronic data management system (e.g., Regulatory Information Management, etc.)
• Diploma or certification in Regulatory Affairs
• Interpersonal skills, problem solving, innovation and proactive, taking ownership, precise, goal oriented
• Leadership, problem solving, interpersonal skills

Skills