Senior Tech Transfer & Regulatory Research Associate

Paladin Labs Inc.; Hinoba-an; On-site; PHP 600,000 - 900,000; Full time

Job summary

Par Health is seeking a Senior Technical Services Associate to lead technology transfer activities, documentation, and filing support across the product lifecycle. You will coordinate submissions, site transfers, and validation, align cross-functional teams, and ensure timely execution while maintaining cGMP standards.

This role emphasizes meticulous document control and collaboration with QA, regulatory, and manufacturing to enable on-time launches.

Responsibilities

• Coordinate technology transfer submissions and site transfer activities.
• Prepare and finalize documents and processes for site execution.
• Align team members and cross-functional teams to meet timelines.
• Update project details in daily, weekly and monthly meetings.
• Perform risk evaluation and gap analysis to determine batch sizes and prerequisites.
• Review and approve engineering, submission and validation documents; participate in gate reviews.
• Monitor batches according to timelines and market needs.
• Prepare placebo and coordinate QC testing as required.
• Support regulatory filings with required documentation.
• Handle investigations to improve quality documentation and propose next steps.
• Manage CMC queries to support timely product approval and readiness for launch.
• Provide commercial support throughout product lifecycle.

Job description

Par Health is seeking a Senior Technical Services Associate to lead technology transfer activities, documentation, and filing support across the product lifecycle. You will coordinate submissions, site transfers, and validation, align cross-functional teams, and ensure timely execution while maintaining cGMP standards.

This role emphasizes meticulous document control and collaboration with QA, regulatory, and manufacturing to enable on-time launches.