16 set - Pomezia
Altro
Your Role
Manage regulatory activities for assigned Rx and OTC products throughout their lifecycle, ensuring compliance with Italian and European regulatory requirements.
Prepare, review and submit regulatory dossiers, including variations, renewals, notifications and maintenance activities, with a particular focus on quality and safety related regulatory variations.
Under supervision, interact with AIFA and other relevant Italian regulatory institutions, ensuring timely and effective management of regulatory requests and communications.
Support the development, review and approval of promotional and advertising materials, ensuring compliance with applicable regulations and company standards.
Manage a portfolio of approximately 10 products, including both local and global brands, collaborating with international and cross-functional teams.
Monitor and interpret regulatory changes, assessing their impact on the company portfolio and proactively proposing appropriate actions.
Collaborate closely with Quality, Medical Affairs, Market Access, Pharmacovigilance, Supply Chain, Marketing,
Global Regulatory, CMC, Internal and ESO Manufacturing Sites, Artwork Dept. and other internal and external stakeholders to ensure regulatory compliance and successful product lifecycle management.
Leverage digital regulatory tools and systems to improve efficiency, data quality and regulatory processes.
Maintain accurate regulatory documentation and databases, ensuring data integrity and audit readiness.
Contribute to continuous improvement initiatives, promoting digital innovation and process optimization within the Regulatory Affairs Italy function.
The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate's experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements.
Who are you
At least 2 years of experi
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