Regulatory Operations Principal Specialist – Pharmaceutical Industry
Location: Mumbai, India
Job Type: Full-Time
Experience Required: 7–15 years in Regulatory Operations, Quality Assurance, or Packaging/Pharma sciences
Job ID: 255942
Role Overview
We are seeking a Regulatory Operations Principal Specialist to lead and manage regulatory operations for global pharmaceutical submissions. This role is responsible for end-to-end oversight of document creation, review, approval, and compliance across the product lifecycle, supporting submissions to US, EU, Japan, and ROW regulatory authorities.
The ideal candidate combines scientific expertise, regulatory knowledge, and leadership experience to ensure high-quality, compliant deliverables while mentoring team members and supporting operational excellence.
Key Responsibilities
Lead regulatory operations, including review and approval of documents, investigations, and regulatory submissions within electronic platforms (e.g., COMET, TruVault).
Manage Non-Conformance (OOS/OOE/OOT) investigations, authoring scientifically compliant reports.
Prepare and maintain quality dashboards, metrics, and improvement plans, including statistics, graphs, and presentations.
Support audits and internal quality checks, ensuring alignment with GxP, ICH, and global regulatory standards.
Facilitate and implement training processes for laboratory and regulatory operations.
Conduct SOP gap assessments, revisions, and implementation in electronic platforms.
Identify potential operational issues, troubleshoot, and implement corrective actions to maintain compliance and efficiency.
Provide leadership in team management, including resource allocation, performance reviews, and mentoring.
Ensure timely, accurate, and compliant deliverables to internal and external clients.
Required Qualifications & Skills
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Pharmaceutical Chemistry, Chemical/Biological Sciences, or equivalent.
Alternative qualifications in Engineering/B.Tech, Packaging, Polymer, or Printing sciences with relevant experience are also acceptable.
Experience:
7–9 years in Regulatory Operations, Quality Assurance, Analytical Science, Packaging, or Pharmaceutical Product Lifecycle management.
Minimum 1+ year in project management and team leadership preferred.
Strong understanding of pharmaceutical regulatory requirements, GxP compliance, ICH-GCP guidelines, and drug development lifecycle.
Proficient in document management systems, MIS, and Microsoft Office applications.
Exceptional analytical, organizational, and time management skills with high attention to detail.
Excellent communication, presentation, and leadership abilities.
Ability to work independently and collaboratively in a global environment.
Proactive, process-driven, and adaptable to evolving business needs.
Preferred Skills
Advanced degree (PhD/Master’s) in relevant pharmaceutical, packaging, or life sciences.
Knowledge of regulatory affairs certifications, data management systems, and MIS reporting.
Experience managing global/regional submissions and cross-functional teams.
Familiarity with project management principles and resource allocation.
Work Environment
Hybrid or office-based work in Mumbai, India.
Travel requirement: 5–10% regional or global travel as required.
Collaborative, fast-paced environment requiring attention to detail and adherence to regulatory timelines.
SEO & GEO Optimized Keywords:
Regulatory Operations Mumbai, Principal Regulatory Specialist India, Pharmaceutical QA Jobs Mumbai, Regulatory Affairs Lead, Compliance & Submission Specialist, Drug Development Lifecycle Jobs India
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