JB-1701 - Assistant Manager - Regulatory Affairs
Rhydburg Biotech · Dehradun, India ·
- Category
- Legal
- 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.