Regulatory Operations Principal Specialist
Location: Mumbai
Employment Type: Full Time
Job Overview
Responsible for executing risk management processes, procedures, and documentation required to support the Quality Risk Management Program for surgical procedures and new combination product development. The role involves providing quality oversight, ensuring compliance with regulatory requirements, and supporting product lifecycle management activities.
Summary of Responsibilities
Execute risk management processes, procedures, and documentation to support the Quality Risk Management Program.
Focus on combination products used in surgical procedures; understanding of surgical procedures is highly beneficial.
Provide quality oversight for new combination product development and lifecycle management activities.
Prepare and deliver technical reports in full compliance with current Good Manufacturing Practices (cGMP).
Collaborate with stakeholders and business partners to identify improvement opportunities and achieve business objectives.
Participate in meetings and calls with global stakeholders, including US-based teams.
Conduct data-driven risk assessments, including risk identification, analysis, evaluation, and mitigation planning.
Support Corrective and Preventive Action (CAPA) initiatives.
Execute responsibilities as defined in Standard Operating Procedures (SOPs).
Coordinate and manage documents within document management systems.
Ensure compliance with procedures, regulatory requirements, and customer expectations.
Troubleshoot technical documentation issues, resolve conflicts, and provide timely solutions.
Work with company leadership to define project objectives, processes, policies, procedures, and governance frameworks.
Maintain strong product knowledge and industry awareness.
Participate in cross-functional meetings and communicate relevant updates to internal stakeholders.
Assist in the generation, review, implementation, and maintenance of SOPs, work instructions, and related documentation.
Support internal and external audits and ensure inspection readiness.
Qualifications (Minimum Required)
Option 1:
Bachelor's degree in Pharmacy or a related Life Sciences discipline.
Master's degree or PhD preferred with relevant experience.
Equivalent experience may be considered in lieu of educational requirements.
OR
Option 2:
Bachelor's degree in Engineering, B.Tech, Packaging, Polymer, Printing Technology, or a related discipline.
Packaging Postgraduate Degree, Diploma, or Certification preferred.
Relevant industry experience in packaging and pharmaceutical manufacturing environments.
Proficiency in English communication (written and verbal).
Experience (Minimum Required)
7–9 years of experience in:
Regulatory Affairs
Quality Assurance
Analytical Sciences
Packaging Development
Polymer or Printing Technologies
Formulation Sciences
Material Management
Drug Development and Manufacturing Processes
At least 1 year of project management and/or people management experience is desirable.
Experience with document management systems and publishing tools.
Strong proficiency in Microsoft Office applications.
Good understanding of:
Pharmaceutical Product Lifecycle
Regulatory Requirements
GxP Regulations
ICH-GCP Guidelines
Strong analytical and problem-solving capabilities.
Customer-focused approach with excellent stakeholder management skills.
Strong verbal, written, and presentation skills.
Leadership and decision-making capabilities.
High attention to detail and accuracy.
Ability to identify risks, anticipate issues, and implement corrective actions.
Experience handling internal and external audits.
Commitment to maintaining client and global regulatory compliance.
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