Regulatory Affairs Specialist

Roche

  • Алматы
  • Постоянная работа
  • Полная занятость
  • 8 ч. назад
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionRoche 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 PurposeAs 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 HeadKey Areas of ResponsibilityTechnical support, i.e., filling out national and EAEU websites for all submissions;Preparing and Tracking contracts with regulatory suppliers and third partiesDownloading 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 testingLabeling of unregistered drugs (Supply Chain support, as well as correspondence with distributors);Request of GMP/CPP documentsPreparing a dossier for localization; full application cycle within the EAEUSupport for national proceduresPartnering with EAEU Hub and Roche HQ for cohesive and efficient operations.Qualifications and RequirementsA 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:Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.

Roche