Regulatory Affairs Specialist

4 settimane fa

Roma, Lazio, Italia Leo Pharma A tempo pieno

**Company Description**
At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.
Every day, we seek inspiration from people living with skin diseases.
We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.
As a purpose-driven company, high performance is measured equally as sales results and the positive impact we create - for health care professionals and their patients.
These aspirations are encapsulated in our perpetual quest for the world's best talent.
The roll will ensure local regulatory strategic insights and optimal pathways to drug development; including relevant local regulatory intelligence.
Secure essential interface with Regional Leads.
**Responsibilities**:
- Responsible for executing specialized projects or activities essential to the achievement of overall functional objectives;
- Maintenance of existing Clinical Trial (where applicable) and Marketing Authorizations;
- Submission of the Clinical Trial Application of new clinical protocol and amendments in the local web portal according to the national requirements.
- Work in accordance with regulatory systems and processes;
- Legal, Medical & Regulatory (LMR) activities for promotional and non-promotional marketing materials, with supervision;
- Proactively secure a constructive regulatory collaboration in the interface with Commercial, Customer Order Management (COM), Global Product Supply, Global Quality Assurance (QA), Pharmacovigilance (PV), Global Public Affairs and Marketing Compliance and other key areas of the business;
- Preparation and maintenance of text for product packaging, patient leaflets, SmPCs, etc.
;
- Regulatory intelligence and networking: Contact with Regulatory Authorities, Trade Associations and other pharmaceutical companies, including attendance at external meetings.
Reading of journals and other published articles;
- Review of new legislation when issued, and sharing information with key stakeholders, as applicable;
- Creation of local regulatory documents in eDOC LEO, as applicable;
- Administrative responsibilities, as required for the role, according to LEO Pharma QMS processes and procedures;
- Monitor and assess new and revised regulatory legislation and guidelines relevant to the roles and responsibilities of the position;
- Communicate new requirements with potential global impact to Regulatory Intelligence Department and relevant stakeholders, including GRT and local affiliate;
- Contribute to ad hoc regulatory projects, as applicable for the market, with some supervision;
- Support constructive and transparent working relationships with the Local Regulatory Authorities and trade associations;
- Effectively communicate, both internally and externally, to key stakeholders, on matters of varying complexity;
- Active participation in RA working groups, as applicable;
- Development of proposals to enhance existing processes and practices;
- Deputize for the Senior RA Professional, or other team members, on an ad hoc basis, including representing LRA at global and external meetings.
**Qualifications**
- Degree in Life Sciences, Pharmacy or equivalent experience.
- Relevant experience in Regulatory Affairs and a good understanding of the drug development process and life cycle management.
- Familiar with submission portals, electronic document management systems, electronic Review Systems (e.g.
Veeva, eRIMS, eDOC and MyDoc) and IT systems (eg MS Word, Excel, PowerPoint, Visio, Lotus Notes and Outlook).
- Stay abreast of scientific and relevant regulatory updates.
Other skills
- Ensures accountability
- Proactive and energetic attitude
- Collaborates cross functionally
- Communicates effectively
- Decision quality
- Attention to details
- Being resilient
**Additional Information

  • Regulatory Affairs Specialist

    1 giorno fa

    Roma, Lazio, Italia Cellnex Italia A tempo pieno

    JOB OVERVIEW: The candidate will be hired in the "Legal & Regulatory Affairs" department, reporting directly to the Head of "Regulatory Affairs". MAIN RESPONSIBILITIES: Management of regulatory disputes before the Italian Communications Authority Support in managing relations with industry associations Ensure compliance with formal requirements provided...

  • Regulatory Affairs Compliance Officer

    1 giorno fa

    Roma, Lazio, Italia Cellnex Italia A tempo pieno

    Job OverviewThe Regulatory Affairs Specialist will be hired in the Legal & Regulatory Affairs department, reporting directly to the Head of Regulatory Affairs.Main ResponsibilitiesManagement of regulatory disputes before the Italian Communications Authority:Ensure compliance with formal requirements provided by sector regulations;Support in managing...

  • Senior Regulatory Affairs Specialist

    1 giorno fa

    Roma, Lazio, Italia JR Italy A tempo pieno

    Social network you want to login/join with: Senior Regulatory Affairs Specialist, ItaliaClient:Location:Job Category:Other EU work permit required:Yes Job Reference:447769579055008972833710 Job Views:3 Posted:28.03.2025 Expiry Date:12.05.2025 Job Description:Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating...

  • Regulatory Affairs Specialist

    5 giorni fa

    Roma, Lazio, Italia TN Italy Lavoro a distanza Freelance A tempo pieno

    Company OverviewTN Italy is seeking a highly skilled and experienced Regulatory Affairs professional to join our team as Contractor Regulatory Manager.The successful candidate will be responsible for providing regulatory support and expertise to our clients, ensuring compliance with all relevant regulations and guidelines.Key Responsibilities:Initiate,...

  • Junior Regulatory Affairs Specialist

    4 giorni fa

    Roma, Lazio, Italia Coswell S.p.A. A tempo pieno

    Sei alla ricerca di una sfida professionale in un contesto dinamico e internazionale? Allora questo è il ruolo che fa per te Stiamo cercando un–Junior Regulatory Affairs Specialist. Principali task: Gestione delle schede di sicurezza (SDS): valutare le schede di sicurezza per i prodotti chimici tramite workflow approvativi; preparare e aggiornare SDS e...

  • Regulatory Affairs Specialist

    2 settimane fa

    Roma, Lazio, Italia Aretè & Cocchi Technology A tempo pieno

    JSB Solutions - azienda leader nei servizi life sciences con focus su consulenza, gestione studi clinici e sviluppo software - ricerca per il potenziamento del proprio organico un Regulatory Affairs Specialist (JSB.PPL.25.008) da inserire all'interno della propria divisione degli Affari Regolatori . Chi siamo: con quattro sedi operative in Italia...

  • Regulatory Affairs Specialist

    1 giorno fa

    Roma, Lazio, Italia Aretè & Cocchi Technology A tempo pieno

    JSB Solutions - azienda leader nei servizi life sciences con focus su consulenza, gestione studi clinici e sviluppo software - ricerca per il potenziamento del proprio organico un Regulatory Affairs Specialist (JSB.PPL.25.008) da inserire all'interno della propria divisione degli Affari Regolatori.Chi siamo: con quattro sedi operative in Italia (Firenze,...

  • Regulatory Affairs Specialist

    2 giorni fa

    Roma, Lazio, Italia Cellnex Italia A tempo pieno

    JOB OVERVIEW: The candidate will be hired in the "Legal & Regulatory Affairs" department, reporting directly to the Head of "Regulatory Affairs". MAIN RESPONSIBILITIES: Management of regulatory disputes before the Italian Communications Authority Support in managing relations with industry associations Ensure compliance with formal requirements...

  • Regulatory Affairs Officer

    2 settimane fa

    Roma, Lazio, Italia Productlife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamoIntexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Regulatory Affairs Professional

    6 giorni fa

    Roma, Lazio, Italia Cosmoimd A tempo pieno

    Job OverviewAt Cosmo Intelligent Medical Devices, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.About the RoleWe are looking for an experienced professional with...

  • Regulatory Affairs Specialist with a Focus on Compliance

    5 giorni fa

    Roma, Lazio, Italia Cosmoimd A tempo pieno

    **Job Overview**We are seeking an experienced Regulatory Affairs Specialist to join our team at Cosmo Intelligent Medical Devices.

  • CMC Regulatory Affairs Manager

    2 settimane fa

    Roma, Lazio, Italia Mantell Associates A tempo pieno

    Mantell Associates is partnered with a Cell & Gene Therapy organisation, who is seeking a CMC Regulatory Affairs Manager to join their growing team. CMC Regulatory Affairs Manager - Responsibilities:Help the team implement and manage CMC regulatory strategies for gene therapy projects, ensuring everything aligns with regulatory requirements. Contribute to...

  • Regulatory Affairs Officer

    3 settimane fa

    Roma, Lazio, Italia ProductLife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma. Chi siamo Intexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile...

  • Regulatory affairs officer

    3 settimane fa

    Roma, Lazio, Italia ProductLife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamoIntexo Società Benefit, una realtà di consulenza del gruppo Product Life, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Junior Regulatory Affairs Specialist

    3 settimane fa

    Roma, Lazio, Italia Cosmoimd A tempo pieno

    Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices. Work Location: Rome – Italy – Viale Ostiense 131/L Key Responsibilities: Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A. Prepare and manage technical dossiers for submission in other countries...

  • Junior Regulatory Affairs Specialist

    2 settimane fa

    Roma, Lazio, Italia Cosmoimd A tempo pieno

    Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices. Work Location: Rome – Italy – Viale Ostiense 131/L Key Responsibilities: Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A. Prepare and manage technical dossiers for submission in other countries...

  • Regulatory Affairs Specialist

    2 settimane fa

    Roma, Lazio, Italia KLISBio s.r.l. A tempo pieno

    Join to apply for theRegulatory Affairs Specialistrole atKLISBio . About The Job At KLISBio, we challenge the status quo in regenerative medicine by leveraging silk as a powerful and biocompatible scaffold material. Our most ambitious goal is to redefine how hard-workingin situtissue engineering is performed, disrupting, with our silk-based technology...

  • Regulatory Affairs Specialist Junior

    3 settimane fa

    Roma, Lazio, Italia JR Italy A tempo pieno

    Social network you want to login/join with: Regulatory Affairs Specialist Junior, RomaClient:Location:Job Category:Other EU work permit required:Yes Job Reference:418328248255827148833710 Job Views:4 Posted:11.03.2025 Expiry Date:25.04.2025 Job Description:Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating...

  • Senior Regulatory Affairs Specialist

    2 settimane fa

    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:10.03.2025Expiry Date:24.04.2025Job Description:Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial...

  • Regulatory Affairs Specialist Junior

    3 ore fa

    Roma, Lazio, Italia Jr Italy A tempo pieno

    Social network you want to login/join with: Regulatory Affairs Specialist Junior, Roma Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 418328248255827148833710 Job Views: 5 Posted: 23.03.2025 Expiry Date: 07.05.2025 Job Description: Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices...