Senior Specialist

3 settimane fa

Milan, Italia Alexion Pharmaceuticals A tempo pieno

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.

Date Posted

23-Mai-2024

Closing Date

25-Juli-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

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