Regulatory Affairs Specialist at F. Hoffmann-La Roche Ltd - Poland

Almaty, , Kazakhstan -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

03 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Technical Support, Interpersonal Skills, Team Player, Growth-Oriented Mindset, Flexibility, Structured Approach, Proficiency in English

Industry

Biotechnology Research

Description

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 Position 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: Who we are A 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Regulatory Specialist will coordinate and support all regulatory activities in Kazakhstan, working closely with regulatory partners. Responsibilities include managing submissions, tracking contracts, and ensuring compliance with regulatory requirements.