Regulatory Affairs Lead

Job Description Summary

-Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

Job Description

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!

Major accountabilities: 

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

 Key performance indicators:

• Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Sandoz policy and guidelines

 Minimum Requirements: 
 

  Work Experience:

• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.
   

 Skills:

• Analytical Skill.
• Clinical Trials.
• Collaboration.
• Detail Oriented.
• Lifesciences.
• Project Planning.
• Regulatory Compliance.
   

 Languages :

• English.

Why Sandoz?

Generic and biosimilar medicines are the backbone of the global pharmaceutical industry. Sandoz, a leader in this sector, provided more than 900 million treatments to patients in over 100 countries in 2024. Through investments in new development capabilities, production facilities, acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients access high-quality, affordable medicines in a sustainable way. Our open and collaborative culture is powered by talented and ambitious colleagues in an agile and collegial environment with impactful, flexible, and hybrid careers—where diversity is welcomed and personal growth is supported.

Commitment To Diversity And Inclusion

We are committed to creating an exceptional and inclusive work environment and diverse teams that represent the patients and communities we serve.

Skills Desired

Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance