Regulatory Affairs 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

Work Experience

• Minimum of 3 years of Regulatory Affairs experience within pharmaceutical companies in Chile.
• Strong knowledge of regulatory processes and requirements with the Institute of Public Health (ISP) .
• Experience preparing regulatory submissions for new product registrations and lifecycle maintenance of pharmaceutical products.
• Flexible mindset, adaptable to change, and proactive approach to work.
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Languages

• English.

Skills Desired

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