Job Description Summary
As a Regulatory Affairs Specialist you will have responsibility for the execution of specific Regulatory Affairs activities at Sandoz country level.Tasks assigned will support in obtaining and maintaining the (to be) registered products, related texts and artworks, and (supporting) the execution of projects.
Job Description
As the global leader in Biosimilar and Generic medicines, Sandoz touches the lives of over 1 billion people worldwide. While we are proud of our achievements, we have an ambition to do more so that everyone can access the basic human right of good health.
To achieve this, we rely on talented individuals who are driven by purpose and the desire to make a real difference in the position of Regulatory Affairs Specialist in Regulatory team Bosnia and Herzegovina, based in Sarajevo and help us create meaningful impact - join us, the future is ours to shape!
Your Key Responsibilities:
As a Regulatory Affairs Specialist you will have responsibility for the execution of specific Regulatory Affairs activities at Sandoz country level.
Tasks assigned will support in obtaining and maintaining the (to be) registered products, related texts and artworks, and (supporting) the execution of projects.
Major accountabilities:
- Guarantees regulatory compliance in execution in line with standards required for regulatory submissions, ensuring adherence to Sandoz standards and local health authority legislation and expectations.
- Guarantees timely creation and translation of official product information, including: Patient Information Leaflets (PILs), Summary of Product Characteristics (SmPCs), and all labelling (packaging texts into artworks).
- Performs regulatory submission and lifecycle management activities using eCTD format, ensuring accuracy, completeness, and compliance with applicable guidelines.
- Manages registration maintenance activities, including product-related text translations and updates.
- Responds to queries from local health authorities regarding registered products in a timely and professional manner.
- Represents company values and behaviors, ensuring clear, professional communication with internal and external stakeholders.
- Provides regular reporting and monitors regulatory legislation changes and industry trends.
- Office-based role (100%).
Requirements:
- University degree of Pharmacy
- Work experience in the same or similar jobs is desirable, but not a requirement
- Strong team-oriented approach and organizational approach
- Good command of English
- Advanced level of MS Office package
- Country language and resident
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 good health.
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
Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory ComplianceSkills Required
- University degree of Pharmacy
- Work experience in same or similar jobs
- Strong team-oriented approach and organizational approach
- Good command of English
- Advanced level of MS Office package
- Country language and resident
- Experience with regulatory submissions and eCTD format
- Knowledge of regulatory compliance, documentation management, and clinical study reports
Sandoz Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.
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Healthcare Strength — Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
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Retirement Support — A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
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Equity Value & Accessibility — Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.
Sandoz Insights
What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
