[Hiring] Senior Executive - Regulatory Affairs @Rhydburg

Role 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.

Qualifications

• 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.

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.

Company Description