QA Regulatory Affairs  

For our client, a privately held biopharmaceutical company active in the fields of reproductive health, urology, gastroenterology, endocrinology, and orthopedics, we are looking for a Senior Analytical Development Lead.

In this role, you will be responsible for ensuring regulatory compliance of CMC activities and documentation, supporting product lifecycle management, and contributing to cross-functional projects in a GMP environment.

Main Responsibilities

• Ensure regulatory compliance of activities performed on site and of corresponding documentation versus regulatory dossiers approved by countries.
• Maintain currency and consistency of regulatory files for Ferring products manufactured on site throughout their product lifecycle
• Support manufacturing site and global projects by checking completeness and correctness of project documentation/records from a regulatory point of view.
• Prepare/update/review CMC (Chemistry, Manufacturing and Control) regulatory documentation for Ferring products manufactured on site throughout their product lifecycle (e.g. CTD Module 2 / Module 3 authoring and requested regulatory documentation for submission to Health Authorities).
• Prepare and review answers to regulatory agency queries received during product registration procedures (new applications, variations, renewals, annual reports, commitments, tenders, etc.).
• Provide expert recommendations and decisions on regulatory issues relating to CMC.
• QA regulatory review of changes and impacts
• Operational activities related to change management system for the site
• Monitoring of the regulatory status for variations and specifications to ensure correct implementation on site.
• Active preparation during HA inspections
• Back up of regulatory staff during absences (variation follow-up)
• Build together with HR L&D and update the training material related to QA RA
• Back up of regulatory staff during absences (variation follow-up)

Requirements

• Bachelor's or Master's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field
• 3 to 5 years of experience in the pharmaceutical industry
• Experience or exposure to CMC regulatory activities is a strong asset
• Good understanding of GMP environment and regulatory requirements
• Strong attention to detail and organizational skills