Job Description Summary
At Sandoz, our Purpose is pioneering access for patientsJob Description
As a Regulatory Affairs Specialist at Sandoz, you will work on registrations, product information and artworks for existing and future products. You combine attention to detail with strong planning skills and collaborate with a range of internal and external stakeholders.
What will you do?
As a Regulatory Affairs Specialist, you ensure that our products and the related product information comply with applicable registration requirements.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- You maintain registration dossiers, prepare official product information and coordinate translations of documents including Patient Information Leaflets, Summaries of Product Characteristics (SmPCs) and packaging texts.
- You are responsible for managing artworks for our product portfolio. You coordinate changes from initiation through implementation and ensure that packaging materials comply with the registered product information, applicable laws and regulations, and internal quality standards.
- You respond to questions from local health authorities and support internal and external audits and inspections.
- You contribute to the earliest possible approval of registration applications and support product launches and manufacturing site transfers.
- You provide general and product-specific Regulatory Affairs support to internal and external stakeholders, including Business Units, Portfolio & Launch, Supply, manufacturing sites, international Artwork teams, Medical and Quality.
- You keep Regulatory Affairs databases up to date and ensure that relevant GxP and RA documentation is archived in accordance with applicable requirements.
- You support local RA projects and develop into a subject matter contact for specific RA processes, tools or projects.
In carrying out your responsibilities, you ensure compliance with Sandoz standards, local procedures, applicable laws and regulations, and health authority requirements. You work accurately, monitor relevant deadlines and maintain professional communication with internal and external stakeholders.
What you’ll bring to the role:
Essential Requirements:
You are detail-oriented and proactive, take ownership of your work and are comfortable working in a highly regulated environment. You can work independently while recognising when alignment with others is needed.
You also bring:
- a Bachelor’s or Master’s degree, preferably in biomedical sciences, pharmacy, pharmacology or a related field;
- Experience in the pharmaceutical industry, preferably in a highly regulated environment;
- Excellent command of Dutch and English, both written and spoken;
- Strong planning and organisational skills with attention to detail;
- Good written communication skills and experience with data management and IT systems, including Microsoft Office;
- Ability to set priorities independently, make informed decisions and deliver high-quality results;
- Ability to look beyond the immediate question or assignment, recognise connections and maintain an overview of the bigger picture.
You’ll receive:
We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.
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
Detail-Oriented, Effective Communication, Regulatory Affairs, Stakeholder ManagementSkills Required
- Bachelor's or Master's degree, preferably in biomedical sciences, pharmacy, pharmacology, or a related field
- Experience in the pharmaceutical industry or a highly regulated environment
- Excellent written and spoken Dutch and English
- Strong planning and organizational skills with attention to detail
- Good written communication skills
- Experience with data management and IT systems, including Microsoft Office
- Ability to set priorities independently, make informed decisions, and deliver high-quality results
- Ability to recognize connections and maintain an overview of broader business priorities
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.
