Regulatory Affairs Manager

13 ore fa

Milano, Italia Pharmalex A tempo pieno

**We are growing, grow with us**
Are you looking for a dynamic company with daily challenges and opportunities?
Then, Pharmalex is your next career move Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally, specialised in all aspects of drugs and medical devices approval of the market development, and any action of effective product maintenance.
**Regulatory Affairs Manager**
Project Manager, strategic and operational support, principally focused on regulatory processes to gain and maintain Italian marketing authorizations for human medicinal products (MAA, renewal, variations), review and submission of promotional materials, support for company set-up with AIFA to support product launch and regulatory maintenance of the products in Italy.
**Your Job**
- Review and submission (where applicable) of promotional and non-promotional materials.
- Strategic and operational customer support with company set-up activities and with national requirements to market medicinal products in Italy.
- Translations and review of Product Information (Linguistic Review).
- Management of activities related to educational materials.
- Communication with Clients and Health Authorities.
- Project Management, execution of activities, progress monitoring until end of project.
- Advisor to Clients on regulatory procedures and requirements in consultation with senior management.
- Advisor to Clients on strategic issues based on experience and knowledge in consultation with senior management.
- Flexibility to respond to client demands (also outside strict regulatory framework) according to required timelines.
- Travel to client meetings as required or participation in TCs.
- Develop and maintain a thorough knowledge of European and national regulatory requirements.
- Maintain the Company's values and work ethos.
- Participation in archiving activities.
**Your Profile**
- University degree in pharmacy or other natural sciences
- 7-10 year experience in Regulatory Affairs department
- Solid experience in review and submission of promotional materials and life-cycle management activities with AIFA
- Project management experience
- Good knowledge of EU and national pharmaceutical legislation
- Ability to analyze and solve problems and to offer solutions for a given task or project
- Very high attention to detail
- High service orientation, flexibility, strong sense of responsibility, organizational skills, autonomous approach to work, ability to process parallel projects and tasks, self-motivation
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors, ability to fit in an international and multicultural environment
- Ability to manage internal and external (client) relationships on operational as well as client's team lead level
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- Italian language is a must; Fluent English, both written and spoken
**We offer**
- An opportunity to work within an organisation with a positive work/life balance environment, one of the leading service companies for the Pharmaceutical Industry globally, in which our values are the backbone of our company, i.e. international mindset, growth and learning, collaboration, quality focus, dynamic working approach and integrity and respect.
- The location of the proposed job is Milan (Italy), and smart working may be an option.
For further information please don't hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity.

  • Cmc Regulatory Affairs Manager

    1 mese fa

    Milano, Italia Fondazione Telethon ETS A tempo pieno

    Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...

  • Cmc Regulatory Affairs Manager

    1 mese fa

    Milano, Italia Fondazione Telethon Ets A tempo pieno

    Fondazione Telethon is one of Italy's leading non-profit organisations.Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases.For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure.We want to change this state of affairs because every person is important to...

  • Cmc Regulatory Affairs Manager

    4 settimane fa

    Milano, Italia Fondazione Telethon Ets A tempo pieno

    Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...

  • Regulatory Affairs Manager

    6 mesi fa

    Milano, Italia Pharmalex A tempo pieno

    **We are growing, grow with us!** Are you looking for a dynamic company with daily challenges and opportunities? Then, Pharmalex is your next career move! Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally, specialised in all aspects of drugs and medical devices approval of the market development, and any action of...

  • CMC Regulatory Affairs Manager

    4 settimane fa

    Milano, Italia Fondazione Telethon ETS A tempo pieno

    Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...

  • Regulatory Affairs Specialist

    1 mese fa

    Milano, Lombardia, Italia Hover Senior Living Community A tempo pieno

    Job 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 pieno

    Azienda 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

    2 settimane fa

    Milano, Italia Buscojobs A tempo pieno

    When our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager / Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a...

  • Senior Specialist

    5 mesi fa

    Milano, Italia Hover Senior Living Community 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...

  • 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...

  • Stage Medical Devices Regulatory Affairs

    1 mese fa

    Milano, Italia Ganassini Corporate A tempo pieno

    Il gruppo Ganassini cerca uno/a Stagista in ambito Medical Devices Regulatory Affairs La persona sarà inserita nel team regolatorio dei Dispositivi Medici a supporto del Medical Devices Regulatory Affairs Manager.Attività principali: supportare le attività di redazione dei fascicoli tecnici di Dispositivi medici a base di sostanze; collaborare alla...

  • Regulatory Affairs Manager

    6 mesi fa

    Milano, Italia GUNA A tempo pieno

    **RUOLO**: Regulatory Affairs Manager - Medical Devices **DIPARTIMENTO**: Regolatorio **JOB DESCRIPTION**: Inserita nel Team Regolatorio e in collaborazione con i colleghi, la nuova risorsa avrà le seguenti responsabilità: - Provvede all'istruzione delle pratiche di autorizzazione, di registrazione e di notifica dei prodotti (ad esempio: medical...

  • Senior Regulatory Affairs Manager

    3 mesi fa

    Milano, Italia Parexel A tempo pieno

    When our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global...

  • Associate Director, Regulatory Affairs

    4 settimane fa

    Milano, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Associate Director, Regulatory Affairs

    2 mesi fa

    Milano, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Associate Director, Regulatory Affairs

    1 mese fa

    Milano, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...

  • Regulatory Affairs Specialist

    1 mese fa

    Milano, Lombardia, Italia Recordati A tempo pieno

    Job DescriptionRecordati is seeking a highly skilled Regulatory Affairs Specialist to join its international team. As a key member of the Corporate Regulatory Affairs department, you will be responsible for the management of regulatory activities for medicinal products for human use.Key Responsibilities:Preparation, review, and submission of relevant...

  • 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...

  • Associate Director, Regulatory Affairs

    2 settimane fa

    Milano, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology.Due...