Job Description

The future is ours to shape.

As a Director Regulatory Lifecycle Management for Biosimilars/Complex Gx, you will be responsible for building and overseeing a high performing team responsible for authoring and reviewing high-quality global CMC documentation for lifecycle management submissions. Your role will involve leading and guiding RLCM staff with respect to workload planning and execution, setting strategic direction for assigned projects, regulatory content development, ensuring technical congruency and regulatory compliance across all projects, and mentoring team members to meet agreed timelines and regulatory requirements. You will collaborate with relevant stakeholders across other global locations as well as Sandoz manufacturing sites, and proactively address critical issues and lessons learned. In addition, you will support departmental operations and foster a culture of regulatory excellence and continuous improvement within your group.

Your key responsibilities:

• Building and overseeing a high-performing team that authors and reviews high-quality global CMC documentation for lifecycle management submissions (biosimilars).
• Ensure accurate planning and execution for tasks assigned to the team.
• Resource planning to cover the full portfolio under your responsibility.
• Accountable for applying the best global and regional CMC strategies for assigned projects, regulatory CMC content strategies for specific tasks, and ensuring technical congruency and regulatory compliance across all submissions
• Ability to develop regulatory CMC content strategies for assigned projects and task within the team
• Foster a culture of regulatory excellence and continuous improvement, ensuring that all activities in the team meet agreed timelines, and regulatory standards.
• Accountable to manage all key stakeholders including MS&T, Supply Chain, Quality and other STO stakeholders as well as other SRA functions including Region Europe, Region International and North America for your assigned portfolio
• Foster collaboration across RLCM groups and all relevant SRA functions
• Identify and flag and address non-compliances proactively.
• Ensure accurate tracking of content and regulatory information within the respective regulatory systems and databases.
• Mentor and grow team member skills to be in line with global expectations for biosimilars and complex products portfolio.

What you will bring to the role:

• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Ph.D.
• Minimum 8 years Regulatory experience with Biosimilars, or at least biotechnology products, commercial stage and minimum 3 years of people manager experience.
• Prior experience in building new teams for international companies is preferred.
• 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: €90,880 – €136,320 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

Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution