Job Title: Regulatory Operations, Principal Specialist
Job ID: 254596
Category: Clinical
Location: Mumbai, India
Work Environment: Office
Role Summary
Provide support for lab compliance activities and regulatory operations, ensuring quality and adherence to applicable standards across client and contract laboratories. Support continuous improvement of quality culture and contribute to regulatory documentation and compliance processes.
Primary Responsibilities
Review and approve documents, including protocols and reports for:
Method qualification
Method validation
Method transfer
Investigations
Handle Quality Issues, Corrective/Preventive Actions (CAPA), and Change Controls for the client and contract laboratories.
Collaborate with supported departments to maintain and improve quality culture and positively influence Quality KPIs.
Actively participate in business meetings such as:
CAPA board meetings
Quality improvement programs
Team connect meetings
Minimum Required Qualifications
Bachelor’s degree in Pharmacy or related science (or equivalent); advanced degree (Master’s or PhD) considered advantageous.
English language proficiency:
Speaking: ILR level 3+ or higher
Writing/Reading: ILR level 4+ or higher
Leadership, problem-solving, and interpersonal skills.
Minimum Required Experience
8–10 years in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, or overall drug development and manufacturing process.
At least 1+ year of project management experience desirable.
Experience with regulatory document formatting and publishing readiness.
Knowledge of regulatory requirements, GxP, and ICH guidelines.
Familiarity with the pharmaceutical product life cycle and internal/external audits.
Technical proficiency in Microsoft Office and Document Management systems.
Preferred Qualifications
Diploma or certification in Regulatory Affairs.
Advanced degree (Master’s/PhD) with relevant experience in Analytical Science, Formulation Science, Material Management, and drug development/manufacturing.
Strong organizational, time management, and analytical skills.
Customer-focused with good review and quality concern skills.
Experience in scientific or clinical research.
Work Environment
Office-based environment.
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