Associate Regulatory Site Officer

at  MindCapture

DO YOU HAVE A PASSION FOR REGULATORY AFFAIRS AND A STRONG UNDERSTANDING OF CMC DOCUMENTATION?

We are urgently seeking a knowledgeable and detail-oriented professional to join the Regulatory Site Officer (RSO) team our client. In this critical role, you will play a vital role in supporting the regulatory management of our pharmaceutical product portfolio.

REQUIRED COMPETENCES & SKILLS

• Bachelor or master in chemistry, pharmaceutical sciences, bio-engineering, or related discipline within pharmaceutical/biotechnology sciences.
• Proven experience in Chemistry, Manufacturing, and Controls (CMC) processes.
• Solid understanding of regulatory requirements for major markets (US, EU, Japan, China, etc.)
• Experience with a regulatory database system, such as Veeva Vault RIM.
• Excellent organizational skills and meticulous attention to detail.
• Strong communication and project management abilities.
• Demonstrated ability to collaborate effectively across functional teams and diverse cultures.

CMC Dossier Management:

• Manage and review CMC (Chemistry, Manufacturing and Controls) dossiers for various pharmaceutical products.
• Handle tasks related to variations, renewals, annual reports, site registrations, and territory extensions throughout the product lifecycle.

Change Control and Documentation:

• Implement change control updates received from partnered sites into existing regulatory dossiers.
• Collaborate with experts and external partners to prepare associated regulatory CMC documentation for submission to regulatory authorities.
• Analyse the impact of proposed changes on existing regulatory submissions.

Compliance Assurance:

• Review operational documentation and reports to ensure alignment with established regulatory requirements.