JB-1602 Senior Executive - Regulatory Affairs

Rhydburg; Dehradun; Remote; INR 600,000 - 900,000; Full time

Benefits offered by this job

Remote working option

Flexible working hours

High technical ownership

Job summary

Rhydburg is seeking a qualified Regulatory/QA professional in India to review analytical methods for APIs and finished products, and to validate documentation in line with ICH guidelines. You will assess specifications and stability data, ensure DMF sections comply, and maintain rigorous records with version control.

Remote options and flexible hours support submission timelines while preserving high technical ownership.

Qualifications

• 3+ years in QC or analytical validation
• Hands-on experience reviewing analytical method validation docs
• Solid knowledge of ICH guidelines and pharmacopeial standards

Responsibilities

• Review analytical methods for APIs and finished drug products.
• Review method validation protocols and validation study reports.
• Assess API and finished product specifications, limits and acceptance criteria.
• Evaluate stability data and shelf-life justifications per ICH guidelines.
• Check DMF analytical sections and critical API quality attributes for compliance.
• Verify analytical compliance for BE study sample testing and reporting.
• Identify gaps in analytical documentation affecting regulatory acceptability.
• Ensure alignment of analytical data with CTD Module 3 structure and expectations.
• Maintain accuracy, traceability, version control and integrity of analytical records.

Skills

Analytical review

Documentation review

Attention to detail

Regulatory knowledge

Education

Bachelor's/Master's in Pharmacy

Tools

CTD alignment

Job description

Job Description

• Review analytical methods for APIs and finished pharmaceutical products.
• Review analytical method validation protocols and validation study reports.
• Review API and finished product specifications, limits, and acceptance criteria.
• Review stability study data and shelf-life justifications in line with ICH guidelines.
• Review DMF analytical sections and critical API quality attributes for compliance.
• Verify analytical compliance for BE study sample testing and reporting activities.
• Identify analytical documentation gaps impacting regulatory acceptability.
• Relevant experince in Quality control or Regulatory Affairs.
• Verify alignment of analytical data with CTD Module 3 structure and expectations.
• Maintain accuracy, traceability, version control, and integrity of analytical records.

Requirements

• Bachelor's or Master's degree in Pharmacy is mandatory.
• Minimum three years experience in QC or analytical validation roles.
• Hands-on experience reviewing analytical method validation documentation.
• Sound working knowledge of ICH guidelines and pharmacopeial standards.
• Strong analytical data interpretation and technical documentation review skills.

Benefits

• 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.