Regulatory Specialist

Roche Central Asia is seeking a dedicated and enthusiastic Regulatory Specialist with a structured approach and a growth-oriented mindset. The role offers an engaging and diverse opportunity within a dynamic and adaptable working environment, where you will be responsible for regulatory tasks. The role is temporary for 3 years (2026, 2027 and 2028).

Joining our team means becoming part of an innovative and highly proactive organization.

Role Purpose

As a Regulatory Specialist, you will be responsible for coordinating and supporting all regulatory activities in Kazakhstan working together with regulatory partners.

The position will report directly to the Science Chapter Head.

Key Areas of Responsibility

• Technical support, i.e., filling out national and EAEU websites for all submissions;
• Preparing and Tracking contracts with regulatory suppliers and third parties;
• Downloading dossiers from Regulatory Information Management system (RIM), proper completion and closing of events, including the withdrawal process for expired drugs, RIM "cleaning" for proper drug deliver, tracking global dispatches, including SmPC;
• Work in internal and external regulatory systems (RIM, ALPIN, etc);
• Ordering standard samples for laboratory testing;
• Labeling of unregistered drugs (Supply Chain support, as well as correspondence with distributors);
• Request of GMP/CPP documents;
• Preparing a dossier for localization; full application cycle within the EAEU;
• Support for national procedures;
• Partnering with EAEU Hub and Roche HQ for cohesive and efficient operations.

Qualifications and Requirements

• A master’s degree in pharmacy, Pharmaceutical Sciences, or related fields;
• Experience in regulatory affairs (at least 1 year);
• Strong personality, capable of working effectively in a regulated environment;
• Systematic and structured approach to work, along with flexibility and excellent interpersonal skills;
• A team player with a growth-oriented mindset, capable of working independently as well as collaborating effectively with colleagues;
• Proficiency in English (oral and written);
• Adaptability to change and a proactive attitude towards optimizing processes.

We are looking for candidates who are motivated to join a fast-paced team working to a high professional standard and demonstrating the following abilities: