Are you an experienced pharmaceutical professional looking to take the next step in your regulatory or analytical career? A Regulatory Operations Specialist II role based in Mumbai offers an excellent opportunity to work at the intersection of analytical science, regulatory operations, and drug development. This full-time position is ideal for candidates who enjoy cross-functional collaboration, scientific problem-solving, and contributing to high-quality regulatory and laboratory outcomes.
With a strong focus on dissolution studies, analytical support, and regulatory compliance, this role plays a critical part in ensuring that pharmaceutical development projects progress smoothly, accurately, and within defined timelines.
🔬 Role Overview
The Regulatory Operations Specialist II is primarily responsible for providing analytical and scientific support to development and comparative dissolution projects received from multiple clients or internal sites. The role requires close coordination with contract research organisations (CROs), external laboratories, suppliers, and internal stakeholders to ensure project efficiency, data integrity, and regulatory readiness.
This position is well-suited for professionals who have hands-on experience in analytical laboratories, understand oral solid dosage forms, and are comfortable working in a GxP-regulated environment.
🧪 Key Responsibilities
As a Regulatory Operations Specialist II, your responsibilities will span scientific, regulatory, and coordination activities, including:
🔹 Analytical & Scientific Support
Providing analytical support for developmental and comparative dissolution projects
Designing and overseeing scientific experiments related to dissolution and formulation studies
Monitoring laboratory activities and interpreting experimental outcomes
Performing comparative and multimedia dissolution testing
Conducting dissolution investigations and troubleshooting instrument or method-related issues
🔹 Documentation & Data Integrity
Preparing and reviewing test methods, protocols, technical reports, and study documents
Ensuring accurate recording, retention, and review of raw data and laboratory records
Analysing dissolution datasets and drawing meaningful scientific conclusions
Maintaining compliance with GMP, safety standards, and data integrity requirements
🔹 Regulatory & Compliance Activities
Supporting regulatory document preparation, formatting, and publishing readiness
Ensuring adherence to GxP, ICH guidelines, and regulatory standards
Assisting during internal and external audits
Demonstrating strong attention to quality and regulatory expectations throughout the project lifecycle
🔹 Collaboration & Project Coordination
Acting as a key interface between internal teams, CROs, and contract laboratories
Coordinating project activities to ensure completion within defined timelines
Supporting continuous improvement in project performance and communication
Working closely with cross-functional teams, including regulatory affairs, quality assurance, and formulation science
🎓 Qualifications & Experience
Minimum Qualifications
Bachelor’s degree in Pharmacy or a related science discipline
4–6 years of experience in one or more of the following areas:
Regulatory Affairs or Regulatory Operations
Quality Assurance
Analytical or Formulation Science
Drug development or pharmaceutical manufacturing
Strong understanding of the pharmaceutical product lifecycle
Proficiency in Microsoft Office and document management tools
Excellent written and spoken English communication skills
Ability to work effectively in regulated, deadline-driven environments
Preferred Qualifications
Master’s degree or PhD in Pharmacy or a related scientific field
Diploma or certification in Regulatory Affairs
Knowledge of data management systems used in pharmaceutical development
Experience with regulatory publishing and submission readiness
Prior exposure to scientific or clinical research environments
💡 Skills That Make You Successful
Strong analytical and problem-solving abilities
close attention to detail with a focus on data accuracy and quality
Effective interpersonal and stakeholder management skills
Ability to handle multiple projects and meet tight timelines
Confidence in addressing audit queries and compliance requirements
Customer-focused mindset with a collaborative approach to work
🏢 Work Environment
Office-based role located in Mumbai
Structured professional environment with cross-functional collaboration
Opportunity to work on global development projects and interact with diverse teams
Apply Now 👇🏻:
https://www.linkedin.com/jobs/view/4336757417
🚀 Why Consider This Role?
This position offers a valuable opportunity to strengthen your expertise in regulatory operations, dissolution science, and pharmaceutical development. If you are passionate about quality, compliance, and scientific excellence, this role allows you to make a meaningful impact while advancing your career in the pharmaceutical industry.
With exposure to regulatory documentation, laboratory coordination, and audit readiness, the Regulatory Operations Specialist II role provides both technical depth and professional growth.
