Senior Regulatory Specialist

Job Summary

To support regulatory compliance and pharmacovigilance efforts, the full-time Senior Regulatory Specialist will develop strategies based on regulatory requirements, serve as a liaison among various stakeholders, and manage regulatory deliverables while working remotely.

Key responsibilities

• Act as Local Contact Person for Pharmacovigilance in the designated country
• Lead projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables
• Provide strategic input to clients and internal teams, identifying and addressing potential risks promptly

Required qualifications

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
• Strong experience in the pharmaceutical or CRO industry or regulatory body
• Good knowledge of ICH GCP and/or GVP and national regulations relevant to the role
• Fluency in English and proficiency in the official language of the country of residence
• PV training and/or relevant working experience as required locally