Job Title: Regulatory Operations Expert
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Work Mode: Office-based (Client Premises) with limited remote flexibility
Application Deadline: January 20, 2026
Job Requisition ID: 262
Job Overview
We are seeking an experienced Regulatory Operations Expert to support global pharmaceutical clients across the US, EU, Japan, and Rest of World (ROW) markets. This role is responsible for managing end-to-end regulatory operations, quality processes, and project execution throughout the product lifecycle.
The position involves team leadership, cross-functional collaboration, regulatory document management, quality oversight, and audit readiness, ensuring all regulatory submissions and quality activities are delivered within agreed timelines and in full compliance with global regulatory standards.
Key Responsibilities
Regulatory Operations & Project Management
Manage, coordinate, and oversee regulatory operations activities related to the creation, revision, compilation, review, approval, and submission of regulatory and labeling documents.
Support global regulatory submissions to US FDA, EMA, PMDA (Japan), and ROW health authorities.
Provide regulatory operations support either as part of client project teams or as a stand-alone service.
Identify potential risks, troubleshoot issues, resolve conflicts, and recommend effective solutions.
Quality Assurance & Compliance
Review and approve regulatory and quality documents within electronic document management systems (e.g., COMET, TruVault).
Investigate Non-Conformances, OOS, OOE, and OOT events and prepare scientifically sound, compliant investigation reports.
Prepare and maintain weekly quality dashboards, metrics, and quality improvement plans (statistics, graphs, and presentations).
Execute and maintain Quality & Compliance (Q&C) dashboards.
Support internal audits, inspections, and internal check rounds.
Process Improvement & Training
Conduct gap assessments of SOPs and support SOP preparation and revision within electronic platforms.
Implement, maintain, and support daily laboratory and quality processes, including training management and reference standard management.
Coordinate and facilitate training programs through digital learning platforms (e.g., Summit).
Drive continuous improvement initiatives aligned with evolving QA and business needs.
People & Stakeholder Management
Manage and mentor team members, including performance reviews, coaching, and skill development.
Support senior management in resource planning and allocation across regulatory projects.
Collaborate effectively across global, multicultural, and cross-functional teams.
Ensure consistent delivery of high-quality, cost-effective regulatory services to internal and external stakeholders.
Qualifications (Minimum Required)
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Sciences, Biological Sciences, or a related scientific discipline
3–5 years of experience in the pharmaceutical or life sciences industry
Strong experience or exposure to laboratory environments, including method development, validation, stability testing, microbiology, pharmaceutical development, or instrument qualification
In-depth knowledge of cGMP regulations and ICH guidelines
Excellent written and verbal communication skills in English
Ability to work across organizational boundaries in a global regulatory environment
Strong adaptability, problem-solving mindset, and agile working approach
Experience Required
10–13 years of total industry experience, with significant exposure to:
Regulatory Affairs
Quality Assurance
Analytical Sciences
Packaging, polymer, or printing streams
Formulation science, material management, or drug development and manufacturing processes
Minimum 5+ years of experience in project management and people management
Proven ability to coach and mentor project teams to strengthen competencies
Experience handling internal and external audits and regulatory inspections
Strong ability to manage deadlines, budgets, and competing priorities
High attention to detail with a strong quality and compliance mindset
Proficiency in MS Word, Excel, and other enterprise systems
Key Skills & Competencies
Regulatory operations and lifecycle management expertise
Strong understanding of ICH, GMP, and global regulatory frameworks
Stakeholder engagement and influencing skills
Analytical thinking with proactive issue identification
Leadership capabilities with a collaborative, team-oriented approach
Ability to work independently in a fast-paced, global environment
Preferred Qualifications
Bachelor’s degree in Pharmacy or related sciences, or an advanced degree (Master’s/PhD) with 10–13 years of Regulatory Affairs or Quality Assurance experience
Engineering / B.Tech background in Packaging, Polymer, or Printing, or a postgraduate qualification in Packaging with 10–13 years of packaging industry experience
Diploma or certification in Regulatory Affairs
Knowledge of data management systems, pharmaceutical product lifecycle management, and MIS
Prior experience in global CRO or multinational pharmaceutical environments
Work Environment & Travel
Work Environment: Office-based (Mumbai) with potential remote flexibility
Travel Requirement: Regional or global travel up to 5–10%, including overnight stays, based on project needs
Why This Role
This position offers an opportunity to work at the forefront of global regulatory operations, contributing to high-impact pharmaceutical projects while collaborating with international stakeholders and regulatory authorities.
Apply now on thepharmadaily.com to advance your career as a Regulatory Operations Expert in a global regulatory and quality-driven environment.
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