Regulatory Affairs Manager

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Generation of high-quality CMC regulatory documentation to support regulatory lifecycle management submissions for the global commercial biosimilar portfolio

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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/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 RA or implement learnings in the global requirements database.

  

What you’ll bring to the role:

Essential Requirements:

• Degree in Science (e.g. Bachelors/Masters degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

• Minimum 8 years Regulatory CMC experience with Biosimilars, or at least biotechnology products, commercial stage

• Fluent English required (oral and written)

• Good knowledge of ICH, EMA, US FDA guidelines and regulatory procedures

• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to understand and critically evaluate data from a broad range of scientific disciplines. Knowledge of the biosimilar development process is desirable.

• Ability to work successfully with global teams and prioritize activities considering agreed timelines and workload.

• Effective planning, organizational and interpersonal skills.

• Computer/IT systems literacy; Quickly adopts and leverages new IT tools to enhance efficiency and collaboration

• Excels at organizing and prioritizing tasks to meet deadlines and deliver high-quality outcomes.

• Communicates and negotiates effectively, building strong relationships across teams and stakeholders.

• Works well under pressure, showing initiative, adaptability, and resilience.

• Plans and organizes with precision, ensuring smooth execution of complex projects.

• Approaches challenges with a solutions-focused mindset, resolving issues proactively.

• Champions teamwork and embrace diversity, creating an inclusive and collaborative culture.

 

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! 

Join us!

 

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance