Regulatory Affairs Specialist

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

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 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 Compliance