Regulatory Operations Specialist II – Mumbai
Category: Clinical | Job ID: 254980
Full-Time
Job Overview
The Regulatory Operations Specialist II is responsible for delivering high-quality analytical support for developmental and comparative dissolution projects. This role serves as a key liaison between internal teams, contract laboratories, clients, and suppliers to ensure compliance, timely project execution, and accuracy in analytical reporting.
Key Responsibilities
Analytical & Scientific Support
Provide analytical support for developmental and comparative dissolution projects from global client sites.
Design scientific experiments and closely monitor laboratory activities to ensure accuracy and compliance.
Interpret dissolution data, analyze trends, and provide detailed scientific conclusions.
Troubleshoot instrumentation, methods, and analytical issues as required.
Project Coordination
Collaborate with CROs, contract laboratories, customers, and peers to define project expectations and improve performance.
Ensure timely project completion through effective coordination and proactive communication.
Manage and document project progress in alignment with regulatory and quality standards.
Documentation & Compliance
Prepare test methods, technical documents, protocols, and reports.
Maintain accurate records, raw data, and documentation according to GMP, safety, and regulatory requirements.
Ensure document compliance with regulatory formatting, publishing standards, and submission readiness.
Technical Expertise
Conduct in vitro dissolution testing, including comparative and multimedia dissolution studies.
Support dissolution investigations and basic formulation-related activities for oral solid dosage forms.
Apply strong understanding of pharmaceutical product life cycles, GxP, and ICH guidelines.
Experience Required
4 to 6 years of experience in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, or drug development and manufacturing processes.
Strong written and verbal communication skills in English (ILR Level 3+ speaking, ILR Level 4+ reading/writing).
Proficiency in Microsoft Office, document management systems, and regulatory publishing tools.
Experience supporting audits, reviewing scientific documentation, and working within a GxP-regulated environment.
Minimum Qualifications
Bachelor’s degree in Pharmacy or a related science field.
Advanced degrees (Master’s or PhD) may be considered.
Equivalent experience may be accepted in lieu of educational requirements.
Strong leadership ability, problem-solving capability, analytical skills, and interpersonal communication.
Preferred Qualifications
Bachelor’s or Master’s/PhD in Pharmacy or a related science field with 4–6 years of relevant experience.
Certification or diploma in Regulatory Affairs.
Knowledge of data management systems and the pharmaceutical product lifecycle.
Demonstrated capability in regulatory document formatting and publishing compliance.
Work Environment
Office-based work environment with adherence to safety, compliance, and organizational guidelines.
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