Regulatory Operations Specialist II – Mumbai, India
Category: Clinical
Job ID: 254980
Employment Type: Full-Time
About the Role
The Regulatory Operations Specialist II will provide analytical and regulatory support for developmental and comparative dissolution projects received from global client sites. This role requires strong scientific expertise, cross-functional coordination, and a solid understanding of pharmaceutical product development and regulatory frameworks.
The position is based in Mumbai and involves collaboration with internal teams, contract laboratories, suppliers, and global partners to ensure timely and high-quality project execution.
Key Responsibilities
Deliver analytical support for developmental and comparative dissolution projects from global client sites.
Act as a liaison with contract laboratories, customers, suppliers, and internal teams to align on project expectations and performance.
Coordinate with CROs to ensure project completion within defined timelines.
Design and monitor scientific experiments, ensuring accurate execution and interpretation of results.
Prepare test methods, protocols, technical documents, and analytical reports as required.
Ensure accurate recording and retention of experimental data and raw information.
Analyze and interpret dissolution data sets for comparative studies.
Troubleshoot issues related to analytical instruments or methods.
Perform assigned activities in compliance with GMP and safety standards.
Conduct in vitro dissolution testing and multimedia comparative dissolution studies.
Manage dissolution investigations and interface with contract labs.
Apply foundational knowledge of oral solid dosage formulation.
Qualifications (Minimum Requirements)
Bachelor’s degree in Pharmacy or a related scientific discipline.
Master’s or PhD preferred; relevant experience may be considered in place of formal education.
Strong English communication skills (Speaking: ILR 3+ | Reading/Writing: ILR 4+).
Proven leadership, analytical thinking, and interpersonal skills.
Experience Required
4 to 6 years of experience in Regulatory Affairs, Quality Assurance, Analytical Sciences, Formulation Sciences, Material Management, or related areas in the pharmaceutical industry.
Strong understanding of the pharmaceutical product lifecycle and drug development processes.
Proficiency in Microsoft Office applications and regulatory document management tools.
Experience with regulatory formatting, publishing readiness, and GxP/ICH guidelines.
Ability to handle internal and external audits.
Prior involvement in scientific or clinical research is desirable.
Strong review skills with a focus on accuracy and quality.
Customer-oriented mindset with strong organizational and time management abilities.
Preferred Qualifications
Bachelor’s or advanced degree (Masters/PhD) in Pharmacy or related sciences with 4–6 years of relevant industry experience.
Certification or diploma in Regulatory Affairs.
Understanding of data management systems and pharmaceutical development lifecycles.
Demonstrated ability in leadership and problem-solving within a regulated environment.
Work Environment
Office-based role with cross-functional engagement across analytical, regulatory, and scientific operations.
Gujarat :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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