Main Accountabilities

Authoring the variations, the CTD sections impacted by the changes, and the renewals of the site products registrations, in compliance with all applicable regulations and company processes

Maintaining and updating regulatory files and databases

Defining the potential regulatory impacts of changes made to the site products and services

Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates

Assisting in internal and external audits, including regulatory inspections

Expected Experience

Experience in regulatory affairs within the pharmaceutical industry, including experience with regulatory preparation of CMC dossier

Expected Technical skills

In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry

Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues

Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance

High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports

Language

Local language and English

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