ACC Regulatory Affairs Distribution Markets Specialist

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

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: 

• Minimum of 2 years of experience in Regulatory Affairs within Latin American countries.
• Experience with regulatory submissions and lifecycle management activities for pharmaceutical products.
• Knowledge of applicable pharmaceutical regulations in at least one Latin American country.
• Experience using regulatory and quality databases.
• Proactive, detail-oriented, and capable of managing multiple projects simultaneously.
• Strong ability to work independently, as the direct manager will be based remotely.

Skills Desired

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