Regulatory Operations Specialist II – Mumbai, India
Location: Mumbai, India
Category: Clinical / Regulatory Affairs
Employment Type: Full-Time
Experience Required: 4–6 years in Regulatory Operations, Quality Assurance, or Analytical/Pharmaceutical Sciences
Job Overview
We are seeking an experienced Regulatory Operations Specialist II to join our clinical and regulatory operations team in Mumbai. This role is integral to supporting developmental and comparative dissolution projects, ensuring compliance with regulatory standards, and facilitating seamless communication between internal teams, clients, and contract laboratories.
The ideal candidate will have a strong background in pharmaceutical development, regulatory operations, and analytical sciences, with experience managing project timelines, reviewing regulatory documents, and supporting quality compliance initiatives.
Key Responsibilities
Provide analytical and regulatory support for developmental projects and comparative dissolution studies received from client sites.
Act as the primary interface with contract laboratories, suppliers, clients, and internal teams to ensure project performance meets timelines and quality expectations.
Design, monitor, and interpret scientific experiments, including dissolution testing and comparative dissolution analysis (including multimedia dissolution).
Prepare, review, and maintain technical documents, test methods, protocols, and reports while ensuring accurate recording and retention of raw data.
Troubleshoot method- and instrument-related issues to maintain smooth operations.
Ensure all activities comply with GMP, safety requirements, and regulatory standards.
Assist in regulatory document formatting, publishing readiness, and submission preparation.
Support internal and external audits, ensuring compliance with GxP and ICH guidelines.
Collaborate across cross-functional teams to improve project efficiency and resolve operational challenges.
Required Qualifications & Experience
Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline. Advanced degrees (Masters/PhD) are preferred.
Experience: 4–6 years in Regulatory Operations, Quality Assurance, Analytical Science, Formulation Science, or related pharmaceutical development and manufacturing processes.
Strong knowledge of the pharmaceutical product lifecycle, regulatory requirements, and ICH/GxP guidelines.
Proficiency in Microsoft Office applications, document management systems, and regulatory publishing tools.
Excellent English communication skills (speaking ILR 3+, reading/writing ILR 4+).
Strong problem-solving, analytical, organizational, and interpersonal skills.
Experience with dissolution testing, formulation science, and comparative analysis is highly desirable.
Preferred Qualifications
Diploma or certification in Regulatory Affairs.
Prior experience in scientific or clinical research.
Proven ability to lead and mentor team members in project execution and regulatory operations.
Work Environment
Office-based role in Mumbai, India.
Exposure to global regulatory operations and collaboration with international teams.
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