Pfizer Regulatory Affairs Advisor in Rome, Italy
This function is responsible for:
Obtainment and maintenance of Marketing authorization for all assigned products
Provide RA input to internal RA stakeholders
Submission of Clinical Trial Applications (CTAs), and subsequent amendments, to the National Competent Authority (NCA)
Ensure all activities are carried out in compliance with Pfizer's SOPs and systems, RA regulations and Ethical codes.
Preparation and submission to AIFA of registration package for new MA submissions or line extensions according to MRP/DCP or National procedures; preparation and/or review of Italian translations for CPs, and any relevant activities.
Preparation and submission to AIFA of all MA variations (Labelling and CMC variations) and MA renewal applications in accordance to the requested timelines.
Check of Module 3 information in order to verify the registered information against what performed by the manufacturing sites. Propose solutions in case of discrepancies or variations requested by manufacturing or Business Units, or required by Health Authorities.
Prepare and submit to AIFA labeling updates for all assigned products in accordance with requests above-country functions or requested by AIFA, ensuring procedural or legislation timelines are met.
Manage all label change implementation activities by liaising with the relevant functions, in compliance with Italian regulation and Pfizer processes and procedures, including - but not limited to - Artwork review and approval, Farmastampati process, German translations for the bilingual Region, etc.
In partnership with above-country operational hubs, above-country strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.
Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
Develop and enhance working relationships with Regulatory Authority.
Utilise local knowledge of Regulatory Authority's expectations, ways of working etc. to appropriately direct company strategy. Share updates with colleagues.
Liaise with clinical research project managers to seek to understand clinical research programme.
Provide Regulatory Affairs information and input to internal stakeholders/customers
Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation.
Knowledge of drug development practice, rules, regulations and guidelines.
Strong quality and compliance orientation
Priority setting and time management capabilities
Bachelor degree or higher in science or health related field, Pharmacy or Chemistry and Pharmaceutical Technology (CTF) are preferred
3 years industry experience in Regulatory Affairs and/or Clinical Trial Management.
Experience in Clinical Trial Applications is required
General knowledge in the EU and Italian Regulation in the pharmaceutical sector
Fluent knowledge in English
Good knowledge of Windows and Microsoft Office
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.