Regulatory Operations Specialist II – Mumbai, India
Job ID: 254980
Category: Clinical / Regulatory Affairs
Location: Mumbai, India
About the Role
We are seeking a Regulatory Operations Specialist II to join our dynamic team in Mumbai. This role involves providing analytical and regulatory support for developmental and comparative dissolution projects, coordinating with contract laboratories and CROs, and ensuring compliance with regulatory standards. The ideal candidate will have 4–6 years of experience in regulatory operations, analytical science, or drug development, and a strong understanding of GxP, ICH guidelines, and pharmaceutical product lifecycle.
Key Responsibilities
Provide analytical support for developmental projects and comparative dissolution studies from client sites.
Serve as a primary interface with contract laboratories, suppliers, customers, and internal teams to define and enhance project performance.
Coordinate with CROs to ensure timely project completion.
Design and monitor scientific experiments; recommend expansion or curtailment based on results.
Prepare and maintain test methods, technical documents, protocols, and reports as required.
Ensure accurate recording and retention of raw data, summarize and interpret results, and draw scientific conclusions.
Analyze dissolution datasets, troubleshoot instrument or method-related issues, and ensure compliance with GMP and safety requirements.
Conduct in vitro and comparative dissolution testing, including multimedia dissolution studies.
Support dissolution investigations and interface with contract labs for technical alignment.
Maintain a basic understanding of oral solid dosage form formulations.
Qualifications & Experience Required
Education:
Bachelor’s degree in Pharmacy, Life Sciences, or related field (or equivalent).
Advanced degrees (MSc, PhD) are advantageous.
Diploma or certification in Regulatory Affairs is preferred.
Experience:
4–6 years in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, or Drug Development & Manufacturing.
Hands-on experience in regulatory document formatting, publishing readiness, and operations.
Knowledge of pharmaceutical product lifecycle, data management systems, and analytical methodologies.
Skills & Competencies:
Strong command of English (writing and speaking).
Proficiency in Microsoft Office Suite and document management tools.
Solid understanding of GxP, ICH guidelines, and regulatory requirements.
Excellent analytical, problem-solving, and organizational skills.
Ability to work effectively under audit situations, both internal and external.
Strong interpersonal, leadership, and customer-focused skills.
Scientific or clinical research experience is desirable.
Work Environment
Office-based role in Mumbai, India.
Collaborative and professional setting supporting regulatory compliance and operational excellence.
Why Join Us
Opportunity to work in a leading pharmaceutical regulatory and analytical operations environment.
Gain exposure to global regulatory standards and cross-functional project management.
Competitive career growth and professional development opportunities in regulatory affairs and clinical operations.
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