Regulatory Site Officer

Descrizione del lavoro:

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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