Junior Regulatory Affairs Ops Specialist

3 giorni fa

Milano, Italia Recordati Group A tempo pieno

**The contex/Company description**
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life
We are currently recruiting a:
**Regulatory Affairs Operations specialist**
The Regulatory Affairs Operations specialist is part of the Corporate Regulatory Affairs team and is responsible to coordinate and execute regulatory activities related to the regulatory systems in place at Recordati Globally.
The Regulatory Affairs Operations specialist is responsible to:
- Manage Regulatory Databases (i.e. Documental Management System, Registration Tracking System, EMA xEVMPD Database)
- Dispatch submission to the relevant authorities through dedicated web portals (i.e. CESP, EMA, PSUR Repository, MHRA portal, FDA Gateway) or affiliate accordingly
- Perform post-submission processing activities such as receiving acknowledgment from authority of submission receipt; archiving electronic receipt; communicate submission receipt to key stakeholders
- Manage the creation, review, approval, distribution of QMS documentation, including procedures and work instructions
- Provide expertise and knowledge to support system users
- Provide mentoring and training to department in specialist areas, as required
- Coordinate implementation and maintenance of global publishing systems (including system testing and validation) and processes
- Manage planning and publishing timeframe of any specific submission, defining priorities and timelines
- Coordinate preparation of reports/product filings for different departments (i.e. Annex H for Pharmacovigilance, Marketing Authorization Status for Regulatory Affairs)
- Manage and maintain xEVMPD database
**_Requirements_**
- 1 years of experience in eCTD publishing sequences, Extedo tool preferred
- Proficiency in use of electronic submission publishing tools and/or document management systems, including knowledge on Computer System validation
- Knowledge of most important guidelines for eCTD preparation and submission (i.e. European, FDA, Canadian, Gulf Council Countries, TGA)
- Veeva Vault and Extedo tool Experience
- Works independently to drive publishing process for routine submissions
- Ability to use Excel, Adobe, Microsoft Word, PowerPoint
- Expert in managing deadlines and priorities
- Analytical and problem-solving skills
- Good organization skills and attention to detail
- Fluent in English
- At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential._
- We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief._

  • Junior Regulatory Affairs Ops Specialist

    7 mesi fa

    Milano, Italia Recordati Group A tempo pieno

    **The contex/Company description** With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and...

  • Regulatory Affairs Specialist

    22 ore fa

    Milano, Italia Werfen A tempo pieno

    For our Quality and Regulatory Affairs Department, based in Milan (Italy), we are looking for a: **REGULATORY AFFAIRS SPECIALIST** The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market. The main accountabilities of the Regulatory Affairs Specialist are: - Support international registrations, understand the local...

  • Regulatory Affairs Expert

    7 giorni fa

    Milano, Lombardia, Italia Flamma spa A tempo pieno

    Job Title:Corporate Regulatory Affairs SpecialistAbout Us:Flamma Group is a leading pharmaceutical company specializing in the development, production, and commercialization of active pharmaceutical ingredients (APIs) and molecules.Job Overview:We are seeking an experienced Corporate Regulatory Affairs Specialist to join our team in Chignolo d'Isola, Italy....

  • Regulatory Affairs Specialist Eu

    7 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 Specialist Eu

    6 giorni 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 Specialist

    15 ore fa

    Milano, Italia Lactalis Italia Srl A tempo pieno

    Gruppo Lactalis Italia è alla ricerca di un/a Regulatory Affairs Specialist da inserire all'interno della funzione Legale.La risorsa, supportando il Regulatory Affairs Manager, si occuperà di: Assicurare l'aggiornamento normativo al fine di recepire le novità sia a livello italiano che europeo e veicolare le informazioni nel Gruppo relativamente...

  • Regulatory Affairs Specialist

    1 giorno fa

    Milano, Italia Lactalis Italia Srl A tempo pieno

    Gruppo Lactalis Italia è alla ricerca di un/a Regulatory Affairs Specialist da inserire all'interno della funzione Legale. La risorsa, supportando il Regulatory Affairs Manager, si occuperà di: Assicurare l'aggiornamento normativo al fine di recepire le novità sia a livello italiano che europeo e veicolare le informazioni nel Gruppo relativamente...

  • Regulatory Affairs Specialist

    14 ore fa

    Milano, Italia Lactalis Italia Srl A tempo pieno

    Gruppo Lactalis Italia è alla ricerca di un/a Regulatory Affairs Specialist da inserire all'interno della funzione Legale.La risorsa, supportando il Regulatory Affairs Manager, si occuperà di:Assicurare l'aggiornamento normativo al fine di recepire le novità sia a livello italiano che europeo e veicolare le informazioni nel Gruppo relativamente...

  • Regulatory Affairs Junior

    3 settimane fa

    Milano, Italia Adh Personal Thüringen A tempo pieno

    Farmapiù, divisione specialistica gruppo Lavoropiù, seleziona un/una Regulatory Affairs junior per un'azienda di distribuzione di materie prime chimiche di Milano (zona Maciachini). La risorsa si occuper di supportare il responsabile nelle seguenti mansioni: gestione tematiche inerenti al regolamento REACH (Joint Submission, update e nuove registrazioni,...

  • Regulatory Affairs Junior

    3 settimane fa

    Milano, Italia Adh Personal Thüringen A tempo pieno

    Farmapiù, divisione specialistica gruppo Lavoropiù, seleziona un/una Regulatory Affairs junior per un'azienda di distribuzione di materie prime chimiche di Milano (zona Maciachini).La risorsa si occuper di supportare il responsabile nelle seguenti mansioni:gestione tematiche inerenti al regolamento REACH (Joint Submission, update e nuove registrazioni,...

  • Regulatory Affairs Specialist

    1 settimana fa

    Milano, Italia Instrumentation Laboratory Spa A tempo pieno

    For 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 Specialist Junior

    2 mesi fa

    Milano, Italia EDGE - A Division of Eurosearch Consultants A tempo pieno

    Edge - Divisione di Eurosearch Consultants, specializzata nella ricerca e selezione di figure specialistiche e di middle management, ricerca per Azienda leader nella distribuzione delle materie prime, una figura di: **REGULATORY AFFAIRS SPECIALIST JUNIOR** **Posizione**: **Responsabilità** La risorsa, riportando al Direttore Affari Regolatori - Quality...

  • Corporate Regulatory Affairs

    22 ore fa

    Milano, Italia NonStop Consulting A tempo pieno

    Regulatory Affairs Specialist/Sr. Specialist The Regulatory Affairs Specialist/Sr. Specialist will be part of the Corporate Regulatory Affairs team and will be responsible for the management of regulatory activities such as obtaining and maintaining marketing authorizations through the implementation of the procedures in use in the European Union (CP, MRP /...

  • Regulatory Affairs Specialist

    7 mesi fa

    Provincia di Milano, Lombardia, Italia Instrumentation Laboratory spa A tempo pieno

    For 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...

  • Tirocinio Regulatory Affairs Specialist

    4 giorni fa

    Milano, Italia GIGROUP A tempo pieno

    Gi Group S.p.A., agenzia per il lavoro (Aut.Min.26/11/04 Prot. N° 1101-SG) ricerca per azienda cliente operante nel settore chimico: TIROCINIO REGULATORY AFFAIRS SPECIALIST La risorsa sarà inserita in stage presso azienda operante nel settore chimico, all’interno dell’ufficio Technical and Regulatory Affairs e, in affiancamento al tutor, si occuperà...

  • Regulatory Affairs Specialist

    7 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 Specialist Junior

    2 mesi fa

    Milano, Italia Edge - A Division Of Eurosearch Consultants A tempo pieno

    Edge – Divisione di Eurosearch Consultants, specializzata nella ricerca e selezione di figure specialistiche e di middle management, ricerca per Azienda leader nella distribuzione delle materie prime, una figura di: REGULATORY AFFAIRS SPECIALIST JUNIOR Posizione: Responsabilità La risorsa, riportando al Direttore Affari Regolatori - Quality Assurance...

  • Regulatory Affairs Specialist Junior

    6 giorni fa

    Milano, Italia Edge - A Division Of Eurosearch Consultants A tempo pieno

    Edge - Divisione di Eurosearch Consultants, specializzata nella ricerca e selezione di figure specialistiche e di middle management, ricerca per Azienda leader nella distribuzione delle materie prime, una figura di:**REGULATORY AFFAIRS SPECIALIST JUNIOR****Posizione**:**Responsabilità**La risorsa, riportando al Direttore Affari Regolatori - Quality...

  • Regulatory Affairs Specialist

    1 settimana 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 Italy,...

  • Tirocinio Regulatory Affairs Specialist

    1 giorno fa

    Milano, Italia Gigroup A tempo pieno

    Gi Group S.p.A., agenzia per il lavoro (Aut.Min.26/11/04 Prot.N° 1101-SG) ricerca per azienda cliente operante nel settore chimico:TIROCINIO REGULATORY AFFAIRS SPECIALISTLa risorsa sarà inserita in stage presso azienda operante nel settore chimico, all'interno dell'ufficio Technical and Regulatory Affairs e, in affiancamento al tutor, si occuperà di:-...