JB-1702 Senior Executive - Regulatory Affairs

Rhydburg; Dehradun; Hybrid; INR 650,000 - 1,000,000; Full time

Job summary

Rhydburg Biotech Ltd. is seeking a Senior Executive - Regulatory Affairs to prepare, review, and maintain regulatory documents and submissions, ensuring compliance with applicable guidelines and company procedures.

You will coordinate regulatory dossiers, applications, renewals, variations, and other submissions; review analytical data and method validation documentation; support regulatory audits and respond to queries; monitor guideline updates and ensure timely regulatory activities with data

Qualifications

• Bachelor's or Master's in Pharmacy required.
• Minimum 3 years in QA or analytical validation roles.
• Hands-on experience reviewing analytical method validation documentation.
• Good communication skills.
• Willingness to work remotely with defined responsibilities.

Responsibilities

• Prepare, review, and maintain regulatory documents and submissions.
• Coordinate regulatory dossiers, applications, renewals, variations, and submissions.
• Review technical documents, analytical data, and method validation information for regulatory compliance.
• Coordinate with QA, R&D, Production, and other departments for regulatory information.
• Support regulatory audits and inspections and respond to regulatory queries.
• Monitor updates in regulatory guidelines and ensure timely regulatory activities.

Skills

Regulatory affairs

QA coordination

Analytical data interpretation

Documentation review

Communication skills

Education

Bachelor's/Master's in Pharmacy

Job description

JB-1702 Senior Executive - Regulatory Affairs

• Industry Pharma/Biotech/Clinical Research

About Us

Rhydburg Biotech Ltd. is a manufacturer, marketer and exporter of pharmaceutical generic products. The organisation's core strength is its strong Research and Development and Regulatory capabilities. The organisation aims to build strong presence in the public and private drug distribution systems through high-quality products.

Job Description

Job Description

Prepare, review, and maintain regulatorydocuments and submissions in accordance with applicable regulatoryguidelines and company procedures.

Compile and coordinate regulatorydossiers, applications, renewals, variations, amendments, andother regulatory submissions.

Review technical documents, productspecifications, analytical data, stability data, and manufacturinginformation for regulatory compliance.

Coordinate with Quality Assurance, R&D, Production, and other departments toobtain regulatory information and documentation.

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

Prepare and coordinate responses toregulatory queries, deficiencies, observations, and requests foradditional information.

Maintain regulatory trackers, submissionrecords, approvals, licenses, certificates, and other regulatory documentation.

Support regulatory audits and inspectionsby preparing required documents and coordinating responses withthe QA and relevant departments.

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

Ensure timely completion of regulatoryactivities while maintaining accuracy, compliance, properdocumentation, and data integrity.

Requirements

Bachelor’s orMaster’s degree in Pharmacy is mandatory.

Minimum three yearsexperience in QA or analytical validation roles.

Hands-on experiencereviewing analytical method validation documentation.

Should have goodcommunication skills.

Strong analyticaldata interpretation and technical documentation reviewskills.

Remote working optionwith defined review responsibilities.

Flexible workinghours aligned to dossier and submission timelines.

High technicalownership without laboratory or shop-floor operations.