Senior Regulatory Officer

1 mese fa

Milano, Italia AstraZeneca A tempo pieno

Senior Regulatory Affairs Officer

Introduction to role

Within the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs). You will ensure the maintenance and compliance to GRP, GMP, Local and Global SOPs, MC Regulatory Process, and Quality Manual of the Italian Marketing Company, as well as Italian and European regulations and legislations.

Accountabilities

Manage the registration application for new products, new indications, and extensions, in compliance with up-to-date national and EU legislation and within the agreed deadlines.

Guarantee the correct maintenance of registered products (renewals, quality and safety updates, labelling requirements, and implementation).

Interact with Italian Regulatory Authorities to resolve any product-related issues (including shortages) to maximize the effectiveness of regulatory authorization with the support of the Line Manager, if necessary.

Ensure compliance to GRP with specific responsibilities including supervising regulatory knowledge traceability, proper archiving of relevant documents related to regulatory activities, and ensuring that Global SOPs and guidance are adopted in local SOPs.

Participate in Issue Management Teams (IMTs) and recall management activities as a back-up of the Local Recall Administrator. Manage communications with Regulatory Authorities following actions determined by the central Issue Management Team, which may include market action. Scope includes all products distributed within Italy.

Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs.

Actively participate in business product teams and local/international meetings.

Estimate the Time to Market (TTM) for AZ products and competitors.

Support Market Access and Marketing for P&R dossier.

Manage special projects like MA transfer with the support of the Line Manager, if necessary.

Manage other regulatory associates for the above-mentioned activities.

Essential Skills/Experience

University Degree in Science or related discipline

Good knowledge of National and EU pharmaceutical legislation

Experience in an area of regulatory affairs

Experience of working on cross-functional teams

Desirable Skills/Experience

Master's degree or equivalent in science/healthcare related field

Prior pharmaceutical industry experience

Experience at a healthcare authority

At AstraZeneca, we are at the forefront of shaping the future of healthcare. Our unique position as medical leaders allows us to drive meaningful change through partnerships with external experts, policy makers, and patient groups. We thrive on innovation and collaboration, working across different markets and functions to deliver science to patients in need. Our dynamic environment offers endless opportunities for growth and development, making a significant impact on patients' lives.

Join us in making a difference - apply today

#J-18808-Ljbffr

  • Senior Regulatory Officer

    1 mese fa

    Milano, Italia Astrazeneca A tempo pieno

    Senior Regulatory Affairs Officer Introduction to role Within the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs).You will ensure the maintenance and compliance to GRP, GMP, Local and Global...

  • Senior Regulatory Officer

    1 mese fa

    Milano, Italia Astrazeneca A tempo pieno

    Senior Regulatory Affairs Officer Introduction to role Within the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs). You will ensure the maintenance and compliance to GRP, GMP, Local and Global...

  • Senior Regulatory Officer

    1 mese fa

    Milano, Italia Astrazeneca A tempo pieno

    Senior Regulatory Affairs OfficerIntroduction to roleWithin the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs). You will ensure the maintenance and compliance to GRP, GMP, Local and Global...

  • Regulatory Affairs Officer

    6 mesi fa

    Milano, Italia HAYS A tempo pieno

    Regulatory, pharma, AIC, consulting **La tua nuova azienda** Il nostro cliente è una rinomata società di consulenza per Aziende farmaceutiche. In ottica di ampliamento dell’organico, siamo alla ricerca di una figura di Regulatory Affairs Officer. **Il tuo nuovo ruolo** In particolare, la posizione prevede: - Supporto per la scrittura di documentazione...

  • Regulatory Affairs Officer

    1 settimana fa

    Milano, Italia Hays A tempo pieno

    Regulatory, pharma, AIC, consulting**La tua nuova azienda**Il nostro cliente è una rinomata società di consulenza per Aziende farmaceutiche. In ottica di ampliamento dell'organico, siamo alla ricerca di una figura di Regulatory Affairs Officer.**Il tuo nuovo ruolo**In particolare, la posizione prevede:- Supporto per la scrittura di documentazione...

  • Regulatory Affairs Officer

    7 mesi fa

    Milano, Italia Adhr A tempo pieno

    **Healthcare & Pharma di ADHR Group, specializzata nella selezione di professionisti nel settore sanitario e farmaceutico, ricerca per prestigiosa azienda leader nel settore farmaceutico un/a**: **REGULATORY AFFAIRS OFFICER** **Le mansioni principali includono**: - Collaborare con il Regulatory Manager di gruppo nella redazione di dichiarazioni e...

  • Regulatory Officer

    1 mese fa

    Milano, Italia Human Value S.R.L. A tempo pieno

    Il nostro cliente è un'azienda italiana di lunga tradizione, leader nella distribuzione di prodotti chimici.Con una presenza consolidata sul mercato da decenni e un respiro internazionale, si distingue per l'eccellenza dei suoi prodotti e l'impegno verso la sicurezza e la sostenibilità ambientale.Per la sua sede di Lainate (MI), siamo alla ricerca di...

  • Senior Compliance Officer

    1 mese fa

    Milano, Italia Saxo Group A tempo pieno

    Senior Compliance Officer Location: Milan, Italy Time Type: Full time Posted On: Posted 3 Days Ago Job Requisition ID: R-16569 About the Job: Would you like to be part of a Global Compliance team where you will play an important role in enabling the development of compliant business? BG SAXO is a partnership between Banca Generali and Saxo Bank,...

  • Senior Compliance Officer

    1 mese fa

    Milano, Italia Binckbank A tempo pieno

    Senior Compliance Officer Location: Milan, Italy Time Type: Full time Posted On: Posted Yesterday Job Requisition ID: R-16569 About the Job Would you like to be part of a Global Compliance team where you will get an important role in enabling the development of compliant business? BG SAXO is a partnership between Banca Generali and Saxo Bank,...

  • Senior Compliance Officer

    1 mese fa

    Milano, Italia Saxo Group A tempo pieno

    Senior Compliance Officer Location: Milan, Italy Time Type: Full time Posted On: Posted 3 Days Ago Job Requisition ID: R-16569 About the Job: Would you like to be part of a Global Compliance team where you will play an important role in enabling the development of compliant business? BG SAXO is a partnership between Banca Generali and Saxo Bank,...

  • Senior Compliance Officer

    1 mese fa

    Milano, Italia Binckbank A tempo pieno

    Senior Compliance Officer Location: Milan, Italy Time Type: Full time Posted On: Posted Yesterday Job Requisition ID: R-16569 About the Job Would you like to be part of a Global Compliance team where you will get an important role in enabling the development of compliant business? BG SAXO is a partnership between Banca Generali and Saxo Bank, providing...

  • Local Compliance and Aml Officer

    7 mesi fa

    Milano, Italia AXA A tempo pieno

    We are looking for a Local Compliance and AML Officer for AXA Partners Italy, based in Milan or Rome. The AXA Partners Compliance and AML Officer is responsible for assisting the Central Compliance Function in implementing and ensuring a robust and effective compliance function across all business units within AXA Partners - CLP Business. The CLP Compliance...

  • Ebury | Compliance Officer

    4 mesi fa

    Milano, Italia Bestforexbonus.Com A tempo pieno

    Ebury | Compliance Officer & MLRO – Italy Job description: Maintain the integrity of the Italian branch. Ensure adherence to legislative requirements and provide support to the wider group. This role requires oversight of regulatory obligations, requirements, and implementing findings into policies and procedures. Be senior enough to have the ability to...

  • Ebury | Compliance Officer

    2 settimane fa

    Milano, Italia Bestforexbonus.Com A tempo pieno

    Ebury | Compliance Officer & MLRO – Italy Job description: Maintain the integrity of the Italian branch. Ensure adherence to legislative requirements and provide support to the wider group. This role requires oversight of regulatory obligations, requirements, and implementing findings into policies and procedures. Be senior enough to have the ability to...

  • Ebury | Compliance Officer

    4 mesi fa

    Milano, Italia Bestforexbonus.Com A tempo pieno

    Ebury | Compliance Officer & MLRO – ItalyJob description: Maintain the integrity of the Italian branch. Ensure adherence to legislative requirements and provide support to the wider group. This role requires oversight of regulatory obligations, requirements, and implementing findings into policies and procedures. Be senior enough to have the ability to...

  • Ebury | Compliance Officer

    2 mesi fa

    Milano, Italia BestForexBonus.com A tempo pieno

    Ebury | Compliance Officer & MLRO – Italy Job description: Maintain the integrity of the Italian branch. Ensure adherence to legislative requirements and provide support to the wider group. This role requires oversight of regulatory obligations, requirements, and implementing findings into policies and procedures. Be senior enough to have the ability to...

  • Regulatory Compliance Officer

    7 mesi fa

    Milano, Italia TerraPay A tempo pieno

    **About Us** **Global money movement, simplified!** - Powering global payments across 7.5 billion bank accounts, 6 billion cards, and 2.1 billion wallets - 121 banking partnerships, 210+ send countries, 140+ receive countries. TerraPay is the pulse of global payments innovation. We're the bridge that connects people and businesses worldwide, empowering...

  • Local Compliance and Aml Officer

    7 mesi fa

    Milano, Italia AXA A tempo pieno

    We are looking for a Local Compliance and AML Officer for AXA Partners SAS, based in Milan or Rome. The AXA Partners Compliance and AML Officer is responsible for assisting the Central Compliance Function in implementing and ensuring a robust and effective compliance function across all business units within AXA Partners - CLP Business. The CLP Compliance...

  • Local Compliance And Aml Officer

    4 giorni fa

    Milano, Italia Axa A tempo pieno

    We are looking for a Local Compliance and AML Officer for AXA Partners Italy, based in Milan or Rome.The AXA Partners Compliance and AML Officer is responsible for assisting the Central Compliance Function in implementing and ensuring a robust and effective compliance function across all business units within AXA Partners - CLP Business. The CLP Compliance...

  • Local Compliance And Aml Officer

    1 settimana fa

    Milano, Italia Axa Assistance Deutschland Gmbh A tempo pieno

    We are looking for a Local Compliance and AML Officer for AXA Partners Italy, based in Milan or Rome. The AXA Partners Compliance and AML Officer is responsible for assisting the Central Compliance Function in implementing and ensuring a robust and effective compliance function across all business units within AXA Partners - CLP Business. The CLP Compliance...