About this role

- Prepare, review, and maintain regulatory submissions
and documentation in compliance with applicable regulatory guidelines.
- Coordinate preparation of dossiers, variations,
renewals, amendments, and other regulatory submissions.
- Review product documentation, specifications,
analytical data, stability data, and manufacturing
information for regulatory compliance.
- Work closely with Quality Assurance, Quality
Control, R&D, Production, and other cross-functional
teams for regulatory requirements.
- Ensure regulatory documents are accurate, complete,
properly controlled, and submitted within defined timelines.
- Support responses to regulatory queries,
deficiencies, observations, and requests for additional information.
- Maintain regulatory databases, submission trackers,
licenses, certificates, approvals, and related records.
- Review and assess QA-related documents, deviations,
CAPA, change controls, SOPs, and quality documentation for
their regulatory impact.
- Monitor changes in regulatory guidelines and assess
their impact on existing products, processes, and documentation.
- Support regulatory audits and inspections by
coordinating required documents, responses, and
compliance-related activities.

Requirements

- Bachelor’s
degree in Pharmacy, Pharmaceutical Sciences, or a related
discipline is mandatory.
- Minimum five
years of experience in Quality Assurance, can consider
candidates who have worked on manufacturing units and has
handled market complaints.
- Strong
knowledge of finished product specifications, analytical
methods, and pharmaceutical laboratory testing
practices.
- Working
understanding of analytical method validation principles and
regulatory requirements for laboratory testing.
- Ability to
review analytical documentation and technical manufacturing
data and coordinate effectively with R&D, QC, QA, and
regulatory teams.

Benefits

- Option to work
from home or from office depending on operational
requirements.
- Exposure to
regulatory operations and pharmaceutical product submission
processes across multiple markets.
- Opportunity to
work closely with manufacturing, analytical laboratories, and
regulatory teams.