Regulatory Affairs Manager for Lifecycle Management Biosimilars/Complex Products (d/f/m)

Job Description Summary

The future is ours to shape.

Job Description

As a Regulatory Affairs Manager for Lifecycle Management Biosimilars/Complex Products, you will be responsible for generation of high-quality Chemistry, Manufacturing and Controls (CMC) regulatory documentation to support regulatory lifecycle management submissions for the global commercial biosimilar portfolio.

Your key responsibilities:

• Author/review high-quality global CMC documentation for lifecycle management submissions, applying agreed global/regional CMC strategies independently for the assigned project.
• Ability to develop regulatory CMC content strategy for an assigned task.
• Ensure technical congruency and regulatory compliance, meeting agreed upon timelines.
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions in collaboration with relevant stakeholders according to associated change controls and negotiate the delivery of technical source documents in accordance with project timelines.
• As needed, identify/coordinate/collect/store source documentation for direct submission to Health Authorities according to the global requirements database.
• Proactively identify critical issues and lessons learned for the assigned project/task. Identify data or documentation issues that require risk mitigation or health authority clarification to ensure timely approval.
• Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
• Actively collect updated CMC requirements from local/regional Regulatory Affairs or implement learnings in the global requirements database.
• Produce high quality regulatory documentation.
• Timeliness of deliverables: No delays in submission and approvals of variations due to late or inadequate submission documentation on matters within RLCMs control.
• Delivers reliable, timely and accurate information / communication about project documentation specific issues within own department and to key stakeholders.
• Regulatory documentation follows Sandoz guidelines and meets regulatory guidelines.
• Builds and maintains collaborative partnerships with stakeholders.

What you will bring to the role:

• Degree in Science (e.g. Bachelors/Masters degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• Minimum 3 years Regulatory CMC experience with Biosimilars, or at least biotechnology products, commercial stage.
• Fluent English required (oral and written).

What we offer:

Job location: Ljubljana

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €50,720 – €76,080 gross

*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

• Annual bonus (STI): percentage of annual salary
• Vacation allowance: in 2025 it was €2,430.99 net
• Christmas bonus: in 2025 it was €2,100 gross
• OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG
• Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary
• Collective life and accident insurance (24/7 coverage)
• A hybrid work environment offering flexibility and remote work possibilities

Ready for your next career move?
You are kindly invited to submit your application in English, including a CV, by July 21, 2026.

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 the ambition to do more so that everyone can benefit from 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 a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

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 where diversity of thought is welcomed and where personal growth is supported! 

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

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

  

#Sandoz

Skills Desired

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