Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant government legislation, and that patient safety and efficacy are at the forefront of business activities. Act as the critical liaison between their organisation, the products they sell and the regulatory authorities by applying their scientific, business and regulatory expertise.
Main activities :
Manage the registration of pharmaceutical products, as well as medical devices and API in your countries and regions.
Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation
Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
Communicate design changes to existing products and company practices where necessary
Plan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals
Stay up to date with the latest rules and regulations
Give presentations to regulatory authorities
Write appropriate standard harmonised regulatory affairs operating procedures for the company
Coordinate local compliance activities :
impact assessment on local Change Control, define the local regulatory strategy for drug product communications, in compliance with local regulation.
Requirements :
Bachelor Degree in Life Science disciplines, preferably in Pharmacy / CTF / Biological Sciences / Chemistry. A specialisation in Regulatory Affairs is a plus.
At least 5 years experience in regulatory field within pharmaceutical industry, preferably in companies with manufacturing sites for medical products
Knowledge of medicines legislation, GMP and reference guidelines.
Experience with AIFA and AGES is prefered.
Experience in using the various applications of the AIFA portal.
Good communication skills – both written and verbal
Skills of team working, critical thinking and planning, meeting deadlines efficiently.
The ability to work under pressure and to tight deadlines
Fluent in both spoken and written English. Fluency in another major European language is preferred.
Regulatory Affair • Bregnano, Lombardia, Italia
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