Job Title: Regulatory Operations Principal Specialist
Location: Mumbai, India
Employment Type: Full-Time
Work Mode: Office-based / Hybrid / Remote (as per business need)
Application Deadline: January 16, 2026
Job Requisition ID: 255944
Job Overview
We are seeking a Regulatory Operations Principal Specialist to lead and manage end-to-end regulatory operations, project management, and cross-functional coordination for global pharmaceutical clients. This role is responsible for overseeing regulatory and labeling documentation across the entire product lifecycle, ensuring timely and compliant submissions to US, EU, Japan, and Rest of World (ROW) health authorities.
The position requires strong leadership capabilities, deep regulatory and scientific expertise, and the ability to manage teams, stakeholders, and complex regulatory deliverables while maintaining the highest standards of quality, compliance, and client satisfaction.
Key Responsibilities
Regulatory Operations & Project Leadership
Lead, coordinate, and oversee regulatory operations activities, including creation, revision, compilation, approval, and submission of regulatory and labeling documents.
Manage regulatory deliverables across the product lifecycle in compliance with global regulatory requirements and agreed timelines.
Provide project management support to client programs and internal teams, ensuring on-time and high-quality delivery.
Scientific & Technical Oversight
Provide analytical and scientific support for developmental and comparative dissolution projects, including multimedia dissolution studies.
Design and monitor scientific experiments; interpret dissolution and analytical data and provide scientifically sound conclusions.
Review, analyze, and troubleshoot issues related to in vitro dissolution testing, methods, and laboratory instruments.
Prepare and review test methods, protocols, technical documentation, and scientific reports as required.
Stakeholder & Vendor Management
Act as a key interface with contract laboratories, CROs, suppliers, and clients to define project expectations and improve performance.
Coordinate with external partners to ensure project milestones are achieved within defined timelines.
Participate in cross-functional and client-facing meetings and cascade relevant information to internal stakeholders.
Quality, Compliance & Process Improvement
Ensure compliance with GMP, GxP, ICH, FDA-SUPAC, and global regulatory guidelines.
Support audits and inspections conducted by clients or regulatory authorities.
Collaborate with Quality Assurance teams to develop SOPs, work instructions, and training materials.
Drive process optimization, productivity improvements, and operational efficiency initiatives.
People Management & Leadership
Manage and mentor team members, including performance reviews, training, and professional development.
Support senior management in resource planning and allocation across projects.
Foster a collaborative, quality-driven, and high-performance team culture.
Qualifications
Education (Minimum Requirement)
One of the following:
Bachelor’s degree in Pharmacy or related science, with 7–9 years of relevant industry experience
Master’s or PhD in Pharmacy or related discipline with equivalent experience
Bachelor’s degree in Engineering / B.Tech (Packaging, Polymer, Printing) with 7–9 years of experience in the pharmaceutical packaging domain
Postgraduate Diploma or Certification in Packaging with 7–9 years of industry experience
Relevant and equivalent experience may be considered in lieu of formal education.
Experience Required
7–9 years of pharmaceutical industry experience in Regulatory Operations, Regulatory Affairs, Quality Assurance, Analytical Sciences, Packaging, Formulation Science, or Drug Development
Hands-on experience in in vitro dissolution testing, comparative and multimedia dissolution studies
Strong knowledge of FDA, ICH, SUPAC, and emerging market regulatory guidelines
Minimum 1 year of experience in project management and people leadership (preferred)
Experience interfacing with contract laboratories and CROs
Understanding of pharmaceutical product lifecycle, manufacturing processes, and regulatory submissions
Core Skills & Competencies
Strong regulatory and scientific knowledge
Excellent analytical and problem-solving skills
High attention to detail and documentation accuracy
Leadership and decision-making capability
Effective stakeholder management and communication skills
Customer-focused mindset with the ability to manage audits and inspections
Proficiency in MS Office, document management, and publishing tools
Preferred Qualifications
Diploma or Certification in Regulatory Affairs
Experience with data management systems and MIS
Exposure to formulation science, particularly oral solid dosage forms
Proven experience driving operational excellence and process improvement initiatives
Work Environment & Travel
Work Environment: Office-based / Hybrid / Remote
Travel Requirement: 5–10% regional or global travel, including overnight stays as required
Why Join This Role
This is a senior-level opportunity to work at the intersection of regulatory operations, scientific expertise, and leadership, contributing to high-impact global submissions while shaping processes, mentoring teams, and driving regulatory excellence.
Apply now on thepharmadaily.com to advance your career as a Regulatory Operations Principal Specialist in the global pharmaceutical industry.
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