Regulatory Affairs Specialist – Procedures

3 settimane fa


Pisa, Italia Regulatory Pharma Net A tempo pieno

Tasks and Responsibilities: Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements.Gives support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.Gives support for the fulfilment of post approval requirements at local level (databases update, PI update, artworks revision, contacts with partners on behalf of MAHs).Gives pre- and post-marketing regulatory consultancies concerning adherence to Italian regulations.Performs the daily review of communications/regulations circulated by the Italian Authorities / EMA.Manages the regulatory procedures in coordination with the Client's team and the contact with Regulatory Authorities together with or on behalf of the client.Gives support to the Client in the critical evaluation of the appropriate regulatory strategy.Essential Requirements: Degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.At least 3 years of experience in similar roles.Soft Skills: Communication and teamwork.Attention to detail and organizational skills.Time management and problem-solving.Adaptability and resilience.
#J-18808-Ljbffr



  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    Tasks and Responsibilities:Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    **Tasks and Responsibilities**: Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national...


  • Pisa (PI), Italia Regulatory Pharma Net A tempo pieno

    Tasks and Responsibilities: Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national...


  • Pisa, Toscana, Italia Biopharmed A tempo pieno

    Job Title: Regulatory Affairs ManagerMain Responsibilities:Develop and implement regulatory strategies to ensure compliance with EU and national regulations. Prepare and submit technical documentation, including MRP, DCP, CP, and National Procedures, for new marketing authorizations, variations, and renewals. Provide support for electronic submission (eCTD)...


  • Pisa, Toscana, Italia Randstad Italia Spa A tempo pieno

    Regulatory Affairs SpecialistRandstad Italia Spa è alla ricerca di un Regulatory Affairs Specialist per rinforzare il suo team di Engineering. La posizione è ideale per chi è interessato a lavorare in un ambiente dinamico e innovativo, con un focus sulla conformità e sulla gestione delle certificazioni.ResponsabilitàCreazione e gestione di una banca...

  • Regulatory Affairs Expert

    4 settimane fa


    Pisa, Toscana, Italia Biopharmed A tempo pieno

    Job Summary:Biopharmed is seeking a highly skilled Regulatory Affairs Manager to join our team. This role is responsible for preparing the strategic approach, technical documentation, and submissions to national and EU portals. The ideal candidate will have a strong understanding of EU regulations and national requirements, as well as excellent...


  • Pisa, Italia Biopharmed A tempo pieno

    Biopharmed: Life Sciences Recruiting **Posizione**: **Biopharmed **is the **head hunting **agency designed to search and select technical and specialized profiles from the **Life Sciences **world. Position: We are looking for a** Regulatory Affairs Manager **for an important service company operating in the regulatory field. **Main responsibilities**: -...


  • Pisa, Italia Biopharmed A tempo pieno

    Biopharmed: Life Sciences Recruiting Posizione: Biopharmed is the head hunting agency designed to search and select technical and specialized profiles from the Life Sciences world.We are looking for a Regulatory Affairs Manager for an important service company operating in the regulatory field.Main responsibilities: Prepares the strategy, the technical...


  • Pisa, Italia Biopharmed A tempo pieno

    Biopharmed: Life Sciences RecruitingPosizione: Biopharmed is the head hunting agency designed to search and select technical and specialized profiles from the Life Sciences world.We are looking for a Regulatory Affairs Manager for an important service company operating in the regulatory field.Main responsibilities: Prepares the strategy, the technical...


  • Pisa, Italia Biopharmed A tempo pieno

    Biopharmed: Life Sciences Recruiting Biopharmed is the head hunting agency designed to search and select technical and specialized profiles from the Life Sciences world.Position: We are looking for a Regulatory Affairs Manager for an important service company operating in the regulatory field.Main responsibilities: Prepares the strategy, the technical...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    translator Afrikaans Albanian - shqipe Arabic - ‎‫العربية‬‎ Armenian - Հայերէն Azerbaijani - azərbaycanca Basque - euskara Belarusian - беларуская Bengali - বাংলা Bulgarian - български Catalan - català Chinese - 中文(简体中文) Chinese - 中文 (繁體中文) Croatian - hrvatski Czech -...


  • Pisa, Italia Randstad A tempo pieno

    Nice to meet you. We are Randstad Digital.Randstad Digital è una società di consulenza globale nei settori Information Technologies e Engineering, con oltre 25.000 esperti in tutto il mondo. Siamo un'organizzazione che mette al primo posto i talenti, e siamo focalizzati nell’abilitare i nostri clienti nei loro percorsi di trasformazione digitale e nello...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    **Tasks and Responsibilities**: Revises promotional/informative/medical materials from a regulatory point of view according to Italian regulations and codes, and performs the submission to the authorities. Transmits the promotional materials through the AIFA portal. Gives support for diseases awareness materials/medical materials/press release/market...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    Tasks and Responsibilities:Revises promotional/informative/medical materials from a regulatory point of view according to Italian regulations and codes, and performs the submission to the authorities.Transmits the promotional materials through the AIFA portal.Gives support for diseases awareness materials/medical materials/press release/market research, and...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    Tasks and Responsibilities: Revises promotional/informative/medical materials from a regulatory point of view according to Italian regulations and codes, and performs the submission to the authorities.Transmits the promotional materials through the AIFA portal.Gives support for diseases awareness materials/medical materials/press release/market research, and...


  • Pisa, Italia Orienta A tempo pieno

    Orienta Healthcare ricerca per azienda farmaceutica leader nel mercato dei servizi regolatori, un Regulatory Affairs Officer. La risorsa sarà chiamata a gestire progetti assegnati, e sarà l'interfaccia del cliente per gli affari regolatori nel mercato europeo. **Requisiti richiesti**: Laurea in Farmacia/CTF/Chimica Industriale/Biologia; Conoscenza delle...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    What will you deal with:Manage promotional materials: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns.Collaborate with cross-functional teams: work closely with marketing, medical, and...

  • Regulatory Affairs

    4 settimane fa


    Pisa, Italia Regulatory Pharma Net A tempo pieno

    **What will you deal with**: **Manage promotional materials**: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns. **Collaborate with cross-functional teams**: work closely with...


  • Pisa, Italia Regulatory Pharma Net A tempo pieno

    What will you deal with: Manage promotional materials: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns.Collaborate with cross-functional teams: work closely with marketing, medical,...


  • Pisa, Toscana, Italia French Consulting A tempo pieno

    Job OverviewThe Regulatory Affairs Administrator will provide customer service and direction to the USAG Community members.Key ResponsibilitiesProvide customer serviceIssue DBIDS CardsPerform administrative dutiesProcess access roster listBasic data entryRequirementsHigh School DiplomaUS citizen over 18 years oldPass a criminal background checkExperience in...