Lead the organization's regulatory strategy, ensuring compliance of pharmaceutical products in all markets where the company operates. Responsible for managing registration, renewal, monitoring, and regulatory compliance processes, aligning internal policies with local and international requirements, and ensuring timely product availability in the market.
Responsibilities:
Define, implement, and oversee the company’s regulatory strategy, ensuring alignment with business objectives and product development goals.
Represent the organization before national and international health authorities.
Assess the regulatory feasibility of new products or markets, anticipating requirements, timelines, and risks.
Ensure regulatory compliance of labels, packaging, inserts, and promotional materials.
Develop and maintain updated internal procedures, regulatory policies, and compliance matrices.
Ensure regulatory compliance in the handling, control, and reporting of narcotics, psychotropic substances, precursors, and chemical substances.
Requirements
Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
Advanced English proficiency.
Experience managing registrations and renewals of pharmaceutical products.