JB-1701 - Assistant Manager - Regulatory Affairs

Rhydburg; Dehradun; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Work from home option

Regulatory operations exposure

Cross-functional collaboration

Job summary

Rhydburg in India (Dehradun) is seeking an experienced Regulatory Affairs and Quality Assurance professional to manage regulatory submissions and related documentation. You will coordinate dossiers, variations, renewals, and ensure compliance across product data, specifications, and analytic data.

Collaborating with QA, QC, R&D, and production, you will address regulatory queries, maintain submission trackers, and support audits and inspections.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related discipline required.
• Minimum five years of experience in Quality Assurance in pharmaceutical manufacturing or market complaints handling.
• Strong knowledge of finished product specifications and analytical testing practices.
• Understanding of analytical method validation and regulatory requirements.
• Ability to coordinate with R&D, QC, QA, and regulatory teams.

Responsibilities

• Prepare, review, and maintain regulatory submissions and documentation.
• 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 with QA, QC, R&D, Production to meet regulatory requirements.
• Ensure documents are accurate, complete, and submitted on time.
• Support responses to regulatory queries and deficiencies.
• Maintain regulatory databases, submission trackers, licenses, certificates, approvals, and records.
• Review QA documents for regulatory impact, deviations, CAPA, and SOPs.
• Monitor regulatory guideline changes and assess impact.
• Support regulatory audits and inspections by coordinating required documents and responses.

Skills

Regulatory submissions

Dossier coordination

QA/QC coordination

Analytical methods

Method validation

Regulatory guidelines

Documentation review

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related discipline

Job description

Job Description:

• 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.

Requirements: