REGULATORY AFFAIRS EXECUTIVE

Brief Summary

Join a dynamic team to ensure compliance and facilitate product registrations through meticulous documentation and regulatory support. Contribute your expertise in a role aimed at driving quality and adherence to industry standards.

Responsibilities

• Assist in the preparation and management of regulatory documents for product registrations and compliance. Collaborate with Quality Assurance, Quality Control, and Operations to address customer regulatory inquiries and documentation requests. Maintain up-to-date regulatory records and ensure compliance with Good Manufacturing Practices (GMP) and relevant standards. Participate in regulatory compliance initiatives, including assessments of changes, deviations, and corrective actions. Monitor and track regulatory submissions and tasks, ensuring they are completed on time and in coordination with the Regulatory Manager.

Requirements

• Bachelor's Degree in Chemistry, Pharmacy, Life Sciences, or a related field. A minimum of 2-4 years of experience in Regulatory Affairs, Quality, or Compliance, particularly within a GMP-regulated setting. Familiarity with international guidelines and standards, including PIC/S GMP and ICH guidelines. Experience with pharmaceutical regulatory submissions and country-specific registrations is advantageous. Strong attention to detail and accuracy in documentation. Excellent organizational and time-management abilities. Proficient analytical and structured thinking skills. Effective written and verbal communication abilities. Self-motivated and dependable, able to work independently while being a collaborative team member. Competence in using MS Office applications.