Regulatory Site Officer

Job description

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 document...