RA Manager

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally.

Join Sandoz and play a key role in ensuring timely patient access to high-quality medicines in Kazakhstan. As a Regulatory Affairs Manager, you will be responsible for managing the full regulatory lifecycle of assigned products, partnering with Health Authorities and cross-functional teams to ensure compliance with local regulations and successful execution of registration activities.

Job Description

Fixed-Term Contract / Maternity Leave Cover

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• Manage the regulatory lifecycle of assigned products, including new registrations, variations, renewals, and other post-approval activities.
• Prepare, review, and submit regulatory applications, dossiers, and supporting documentation to Health Authorities in Kazakhstan.
• Coordinate and provide timely responses to Health Authority requests and regulatory inquiries.
• Ensure compliance of labeling, packaging materials, prescribing information, registration certificates, and other regulatory documents with approved dossiers, company requirements, and local legislation.
• Support import permit activities and coordinate documentation related to samples, standards, and customs clearance processes.
• Maintain accurate and up-to-date product information in global and local regulatory databases.
• Monitor and assess changes in local pharmaceutical legislation, communicating their impact to relevant stakeholders.
• Collaborate with local, regional, and global teams to identify regulatory risks, develop mitigation plans, and support business continuity.

KPI

• Timely submission and approval of regulatory applications in line with business and regulatory timelines.

 

What you'll bring to the role:

Essential Requirements:

• University degree in Pharmacy, Medicine, or another relevant discipline.
• Experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of medicinal product registration, variation, and renewal processes in Kazakhstan.
• Good understanding of local pharmaceutical legislation and regulatory requirements.
• Experience preparing and maintaining regulatory dossiers and regulatory documentation.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Adobe Acrobat Professional.
• Strong communication, stakeholder management, organizational, and problem-solving skills.
• Fluent Kazakh and Russian; advanced English language proficiency.

 

 Compensation Structure & Criteria: 

In addition to a market-competitive base salary, we offer an incentive program, limit on corporate mobile communication, lunch allowance, employee recognition scheme, learning and development options as well as worldwide career opportunities. Unleashing the potential of our people, we offer our corporate wellness program, which includes health & medical insurance, 28 days of annual leave, employee assistance program, parental or maternity leave, flexible and remote working where possible.

 

 

Why Sandoz?

 

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more, so that everyone can achieve the basic human right of access to good healthcare.

 

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. 

 

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! 

 

Join us, help us make healthcare fairer and faster. 

 

 

Commitment to Diversity & Inclusion: 

 

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

#Sandoz

 

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Regulatory Compliance, Waterfall Project Management