Job Description

• Prepare, review, and maintain regulatory
documents and submissions in accordance with applicable regulatory
guidelines and company procedures.

• Compile and coordinate regulatory
dossiers, applications, renewals, variations, amendments, and
other regulatory submissions.

• Review technical documents, product
specifications, analytical data, stability data, and manufacturing
information for regulatory compliance.

• Coordinate with Quality Assurance, R&D;, Production, and other departments to
obtain regulatory information and documentation.

• Review QA documents such as deviations,
CAPA, change controls, SOPs, and batch-related documents for
regulatory requirements and impact.

• Prepare and coordinate responses to
regulatory queries, deficiencies, observations, and requests for
additional information.

• Maintain regulatory trackers, submission
records, approvals, licenses, certificates, and other regulatory documentation.

• Support regulatory audits and inspections
by preparing required documents and coordinating responses with




the QA and relevant departments.

• Monitor updates in regulatory guidelines
and evaluate their impact on products, processes, documentation,
and quality systems.

• Ensure timely completion of regulatory
activities while maintaining accuracy, compliance, proper
documentation, and data integrity.

Requirements
• Bachelor’s or
Master’s degree in Pharmacy is mandatory.

• Minimum three years
experience in QA or analytical validation roles.

• Hands-on experience
reviewing analytical method validation documentation.

• Should have good
communication skills.

• Strong analytical
data interpretation and technical documentation review
skills.

Advantages
• Remote working option
with defined review responsibilities.

• Flexible working
hours aligned to dossier and submission timelines.

• High technical
ownership without laboratory or shop-floor operations.

📌 Senior Executive (Dehradun)
🏢 Rhydburg
📍 Dehradun