Senior Regulatory Consultant

2 settimane fa


Roma, Lazio, Italia Planet Pharma A tempo pieno

Location: Hybrid - Uxbridge/Cambridge
Planet Pharma is partnered with a global leading CRO company who are currently seeking a Senior Regulatory Consultant on a predominantly remote basis.

Main Responsibilities: Provide local regulatory and technical support for assigned products, including product development documentation, regulatory submissions, and project management.
Ensure correct application of national requirements for Marketing Authorization Applications (MAAs) and variations for Centrally Approved products.
Review and approve translations for artworks and product information.
Evaluate promotional and non-promotional materials for compliance with local regulations.
Act as a local regulatory expert in multidisciplinary project teams, collaborating with clinical and technical experts throughout the product lifecycle.
Provide regulatory expertise and support team members in resolving day-to-day regulatory challenges by offering practical solutions.
Main Requirements: Previous strong experience in regulatory affairs within pharma or biotech or CRO.
Experience with Italian regulatory submissions - variations, agencies queries handling, MAAs.
Experience managing negotiations with AIFA.
Interested?
Apply now for immediate consideration or contact Maria Tsalpatourou at
Seniority levelAssociate Employment typeFull-time Job functionScience Industries: Pharmaceutical Manufacturing and Biotechnology Research We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

#J-18808-Ljbffr



  • Roma, Lazio, Italia Planet Pharma A tempo pieno

    Job SummaryProvide regulatory and technical support for assigned products, including submissions, documentation, and project-related regulatory activities.Key Responsibilities:Stay updated on local regulatory requirements, communicating changes to stakeholders.Handle inquiries on compassionate use, early access programs, labeling exemptions, and clinical...


  • Roma, Lazio, Italia Jefferson Wells A tempo pieno

    On behalf of our client - important pharmaceutical group - we are looking for a CMC Regulatory Senior Specialist Ensuring high quality contents for regulatory CMC documentation in line with applicable guidelines for new and approved Drug Products and/or Drug Substances of Company Group in Europe, USA and other countries.Key Responsibilities: Authoring of CMC...


  • Roma, Lazio, Italia Cattaneo Zanetto & Co. A tempo pieno

    **CATTANEO ZANETTO & CO.**POLITICAL INTELLIGENCE LOBBYING PUBLIC AFFAIRS**Consultant specialist in Life Science | Roma**The Consultant will work together with the Partner, the Director and the Senior Consultants heading the relevant practice within the firm.In particular, he/she will have to manage projects of advocacy, lobbying and coalition building both...

  • Regulatory Consultant

    4 settimane fa


    Roma, Lazio, Italia Ramboll Group AS A tempo pieno

    Do you want to push the boundaries of your profession and develop your excellence in an open, collaborative, and empowering culture? Are you enthusiastic about contributing to high-quality health & safety management? Are you motivated by creating sustainable change that benefits society and nature? If this sounds like you, or you're curious to learn more,...


  • Roma, Lazio, Italia TN Italy A tempo pieno

    Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise, Province of Pescara Client: Johnson & Johnson Location: Province of Pescara, Italy Job Category: Other EU work permit required: Yes Job Reference: fe6dce430c7b Job Views: 12 Posted: 06.03.2025 Expiry Date: 20.04.2025 Job Description: We are looking for...


  • Roma, Lazio, Italia Tn Italy A tempo pieno

    Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise, Province of Pescara Client: Johnson & Johnson Location: Province of Pescara, Italy Job Category: Other EU work permit required: Yes Job Reference: fe6dce430c7b Job Views: 12 Posted: 06.03.2025 Expiry Date: 20.04.2025 Job Description: We are looking for...


  • Roma, Lazio, Italia Eligo Recruitment A tempo pieno

    Senior Process Mining Consultant Sei un esperto di Process Mining e vuoi guidare progetti di trasformazione digitale in un'azienda dinamica?Stiamo cercando un Senior Process Mining Consultant per un'importante realtà con sede principale nel Lazio.Il Ruolo Come Senior Process Mining Consultant, avrai un ruolo chiave nella consulenza strategica e...


  • Roma, Lazio, Italia Eligo Recruitment A tempo pieno

    Senior Process Mining Consultant Sei un esperto di Process Mining e vuoi guidare progetti di trasformazione digitale in un'azienda dinamica? Stiamo cercando un Senior Process Mining Consultant per un'importante realtà con sede principale nel Lazio. Il RuoloCome Senior Process Mining Consultant, avrai un ruolo chiave nella consulenza strategica e...


  • Roma, Lazio, Italia Eligo Recruitment A tempo pieno

    Senior Process Mining Consultant Sei un esperto di Process Mining e vuoi guidare progetti di trasformazione digitale in un'azienda dinamica? Stiamo cercando un Senior Process Mining Consultant per un'importante realtà con sede principale nel Lazio. Il RuoloCome Senior Process Mining Consultant, avrai un ruolo chiave nella consulenza strategica e...


  • Roma, Lazio, Italia Meet Life Sciences A tempo pieno

    About Meet Life SciencesMeet Life Sciences is seeking a highly skilled Regulatory Affairs Consultant to join their Italy affiliate team. As a freelance/contract opportunity, this role will be instrumental in supporting the company's growth and success.Key Responsibilities:Preparation and review of scientific information for regulatory purposesReview of...


  • Roma, Lazio, Italia Cosmoimd A tempo pieno

    Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices. Work Location: Rome – Italy – Viale Ostiense 131/L Key Responsibilities: Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and...


  • Roma, Lazio, Italia Cosmoimd A tempo pieno

    Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.Work Location: Rome – Italy – Viale Ostiense 131/LKey Responsibilities:Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and provide...


  • Roma, Lazio, Italia Cosmoimd A tempo pieno

    Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices. Work Location: Rome – Italy – Viale Ostiense 131/L Key Responsibilities: Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and...

  • Senior Sales Consultant

    4 settimane fa


    Roma, Lazio, Italia Unknown A tempo pieno

    Importante realtà ricerca un Senior Sales Consultant. Principali responsabilità La figura di Sales Development & Partnership si occuperà della vendita diretta di prodotti e soluzioni di Digital Marketing per il segmento Medium & Large Enterprise e nello specifico: Contribuire alla progettazione dell'offerta e strutturare la rete di vendita diretta per...


  • Roma, Lazio, Italia Meet Life Sciences A tempo pieno

    About Meet Life Sciences and the RoleMeet Life Sciences is a leading organization in the life sciences industry, dedicated to delivering innovative solutions and services. We are currently seeking a skilled Regulatory Affairs Consultant to join our Italy affiliate team as a freelancer/contractor.Key Responsibilities:Support the development and implementation...

  • Senior Consultant

    5 giorni fa


    Roma, Lazio, Italia Strategic Management Partners A tempo pieno

    Unisciti a Strategic Management Partners come Senior ConsultantSiamo una società di consulenza in forte crescita, attiva in molteplici Industry.Per potenziare la crescita del territorio NORD-EST, stiamo cercando Senior Consultant con esperienza in società di consulenza di direzione o system integratorCosa offriamo:- Ambiente di lavoro stimolante: Lavorerai...


  • Roma, Lazio, Italia JR Italy A tempo pieno

    Social network you want to login/join with:Senior Regulatory Affairs Specialist, RomaClient:Location:Job Category:OtherEU work permit required:YesJob Reference:516766534730147430433710Job Views:4Posted:23.03.2025Expiry Date:07.05.2025Job Description:Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial...


  • Roma, Lazio, Italia MMS Holdings Inc A tempo pieno

    At MMS Holdings Inc, we are seeking a highly skilled Senior Medical Writing Consultant to join our team. As a member of our team, you will play a key role in critically evaluating and analyzing medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.The ideal candidate will...


  • Roma, Lazio, Italia IQVIA Argentina A tempo pieno

    IQVIA Argentina is seeking a highly skilled Senior Medical Liaison Consultant to join our team.The ideal candidate will possess a strong background in medical science, excellent communication skills, and the ability to work effectively with healthcare professionals.As a Senior Medical Liaison Consultant, you will be responsible for establishing and...


  • Roma, Lazio, Italia JR Italy A tempo pieno

    Sei un esperto di Process Mining e vuoi guidare progetti di trasformazione digitale in un'azienda dinamica? Stiamo cercando un Senior Process Mining Consultant per un'importante realtà con sede principale nel Lazio.Il RuoloCome Senior Process Mining Consultant, avrai un ruolo chiave nella consulenza strategica e nell'implementazione di progetti di Process...