Senior Specialist , Regulatory Affairs

Regulatory Affairs Senior Specialist

Reports to:  Director, Italy Regulatory Affairs and Quality

Location: Milan, Italy

Position Summary

The Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.

The Regulatory Affairs Senior Specialist supports interactions with the national Regulatory Authorities, i.e. AIFA and Ministry of Health.

Principal Responsibilities

This position contains tasks related to regulatory area.
Tasks may change over time across and within the respective areas depending on Alexion business needs.

Support the Regulatory Affairs team in the planning, coordination and management of regulatory activities:

• Regulatory submissions to national regulatory authorities as needed (e.g. educational materials)
• Manage labeling activities i.e. translation checking and implementation into national texts (SmPC, package leaflet and labeling) as per local requirements and internal processes
• Ensure approved Annexes and packaging changes Artworks are implemented timely, for products under its own responsibility
• Regulatory revision of educational materials, if required.
• Partner with local pharmacovigilance department in implementing the Risk Management Plan (educational materials, certificate of vaccination and all activities related with the RMP
• Regulatory review and submission to HA of promotional and non-promotional materials in accordance with the Pharmaceutical Law 219/2006, AIFA guidelines, internal SOPs and Farmindustria Code.
• Periodic communications to Regions and AIFA on RAM’s promotional activities
• Preparation and notification of RAM’s badge and documentation, as requested by regulatory authorities and regional regulations
• Maintenance of the regulatory quality management system (QMS), follow-up with Corrective Action Preventative Actions (CAPAs) and changes
• Drafting and updating SOPs under regulatory responsibility.
• Provide support in the training on SmPC/Educational Materials, if required.
• Maintain compliance of the managed activities and assure proper archiving of all relevant documents related to those activities.
• Support the regulatory team during audit and inspection.
• Monitor regulatory/pharmaceutical regulations (Regulatory intelligence) for the relevant therapeutic areas and share information internally.
• Can be assigned as Lead to specific products and projects.

Qualifications

• At least 4-year experience in the pharma industry in regulatory affairs, including experience in a similar position. Previous experience in biotech industry will be a plus
• Good knowledge of applicable local and global pharmaceutical regulations and related ethical code of practice required for GXP compliance
• Ability to pragmatically interpret GxP and Code of Practice regulations, laws and guidelines with ability to share
• Experience in review of promotional and non-promotional materials and activities.
• Strong written and verbal communication and organizational skills
• Ability to work independently and collaborate effectively with cross-functional colleagues (e.g. quality, drug safety, medical, marketing) at all levels of the organization.
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
• Ability to multi-task and prioritize work.
• Fluency in English (speaking, reading, and writing)
• Knowledge in QMS activities and Electronic Quality Systems.
• Proficiency in Microsoft applications (Excel, Word, PowerPoint)

Education

• Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, etc.).

• Master in Regulatory Affairs will be a plus.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.