Regulatory Affairs Officer- Maternity Cover
5 mesi fa
**The contex/Company description**
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
**Your contribution/mission**
You will report to the Regulatory Affairs Manager-International and you will be be responsible for the management of all regulatory activities related to assigned products and geographical area.
You will take care of the preparation, review and submission to regulatory authorities of all relevant documentation and management in the identified IT systems of the data and documentation to support new product registration and/or maintenance of products in the various market.
You will coordinate the preparation of discussions and negotiation with Regulatory Agencies; manage and coordinate preparation of core dossiers for corporate products; coordinate interaction with the group's affiliates, licensees and consultancy; monitor the legislation in force; define a plan and costs of the required activities.
**Your profile**
You have a scientific bacherlor's degree and at least 1 year experience in a similar role, preferably in CROs or pharmaceutical companies.
You are fluent in english and expert in Microsoft Office and DMS.
**Additional information**
Location: Milan
Direct Manager: Regulatory affairs manager
- International
Fixed term contract for a maternity cover
- “At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone's contribution and achievements can be appropriately rewarded.”_
-
Regulatory Affairs Officer
5 mesi fa
Milano, Italia HAYS A tempo pienoRegulatory, 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 Specialist
6 mesi fa
Milano, Italia AstraZeneca A tempo pieno**Regulatory Affairs Specialist (maternity leave)** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As **Regulatory Affairs Specialist (maternity leave)** in...
-
Regulatory Affairs Officer
6 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 Affairs Specialist
6 mesi fa
Provincia di Milano, Lombardia, Italia Instrumentation Laboratory spa A tempo pienoFor our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a: **Regulatory Affairs Specialist - Maternity Leave**: The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market. The main accountabilities of the Regulatory Affairs Specialist are: Support registrations, understand the local...
-
Regulatory Affairs Director
4 settimane fa
Milano, Lombardia, Italia Parexel A tempo pienoRegulatory Affairs Director Job DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to lead our team's regulatory efforts. As a Director, you will be responsible for ensuring compliance with regulatory requirements and guidelines, providing guidance to project teams, and managing performance and development of staff...
-
Regulatory Affairs Expert
3 settimane fa
Milano, Lombardia, Italia The Kraft Heinz Company A tempo pienoJob Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Kraft Heinz Company. As a Regulatory Affairs Manager, you will be responsible for ensuring all product labels used by Kraft Heinz in Europe comply with food legislation, government guidelines, and company policies, with a...
-
Regulatory Affairs Director
1 mese fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join their team. This role offers a unique...
-
Regulatory Affairs Director
1 mese fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Regulatory Affairs Director to join their team. The ideal candidate will have a sound understanding of new registrations and...
-
Regulatory Affairs Consultant
1 mese fa
Milano, Italia Hays A tempo pienoLa 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 Sotto la supervisione di team leaders e inserito/a in un ristretto team, il/la candidato/a svolgerà la sua attività nell'ambito...
-
Regulatory Affairs Specialist
4 settimane fa
Milano, Lombardia, Italia Hover Senior Living Community A tempo pienoJob SummaryThe 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....
-
Regulatory Affairs Specialist Eu
6 mesi fa
Milano, Italia Clinglobal Group A tempo pieno**Regulatory Affairs Specialist - European Union** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work...
-
Regulatory Affairs Cmc
6 mesi fa
Milano, Italia HAYS A tempo pienoAzienda Farmaceutica - Affari Regolatori - Regulatory Affairs CMC - GMP La tua nuova aziendaIl nostro cliente è una realtà multinazionale che produce e commercializza prodotti farmaceutici generici.Il tuo nuovo ruoloIn ottica dell’ampliamento dell’organico, siamo alla ricerca di una figura di Regulatory Affairs CMC.La risorsa risponderà direttamente...
-
Senior Regulatory Affairs Manager
1 mese fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Senior Regulatory Affairs ManagerJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking a Senior Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for the strategic lifecycle management of...
-
Senior Regulatory Affairs Expert
4 settimane fa
Milano, Lombardia, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceAbout the Role:As a key member of our Regulatory Affairs team, you will be responsible for the strategic lifecycle management of our Medical Devices. This includes oversight of all activities required for the successful and smooth integration of new products following...
-
Regulatory Affairs Manager
4 settimane fa
Milano, Lombardia, Italia W Executive S.R.L. A tempo pienoJob Description: We are seeking a highly skilled Regulatory Affairs Manager to join our team at W Executive S.R.L. The successful candidate will be responsible for ensuring that all our products meet the relevant government legislation and regulations, while prioritizing patient safety and efficacy. The main responsibilities of this role include:Managing the...
-
Senior Regulatory Officer
3 settimane fa
Milano, Italia Astrazeneca A tempo pienoSenior 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
3 settimane fa
Milano, Italia Astrazeneca A tempo pienoSenior 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 Specialist
5 mesi fa
Milano, Italia Hover Senior Living Community A tempo pienoRegulatory 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...
-
Senior Regulatory Officer
3 settimane fa
Milano, Italia Astrazeneca A tempo pienoSenior 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...
-
Senior Regulatory Officer
3 settimane fa
Milano, Italia AstraZeneca A tempo pienoSenior 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...