Regulatory Affairs Manager

4 settimane fa

Roma, Italia Ergomed A tempo pieno

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Due to continued growth, we are seeking a Computer Systems Validation/IT QA Specialist

**Job Description**:
Ergomed is looking for a Regulatory Affairs professional with in-depth Clinical Trials experience, who would like to expand their knowledge to full life cycle management including Orphan Drug Designations, Paediatric Investigational Plans and Marketing Authorisation Applications to join our expanding team.

**KEY RESPONSIBILITIES**:

- Prepare, collect, review and submit documentation related to clinical studies (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.) to the relevant regulatory authorities and IRB/EC and act on the Sponsors behalf in liaising with these authorities
- Act as Regulatory Lead for global clinical trials of low/medium/high complexity ensuring effective and rapid coordination and management of regulatory & ethics committee submission, striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets.

**Qualifications**:

- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Minimum 4 years of regulatory experience within pharmaceutical/CRO industry
- Preferably one proven area of expertise within the regulatory affairs environment (i.e. CMC, MDs, Orphan Drugs, Advance Therapies, etc)

Other skills and abilities:

- Previous experience in managing clinical trials globally
- Clear understanding of ICH GCP across all areas
- Good written and verbal communication skills to clearly and concisely present information

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

LI-Remote

  • Regulatory Affairs Specialist

    6 giorni fa

    Roma, Italia ManpowerGroup A tempo pieno

    Azienda: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO Descrizione: **Il nostro Cliente**: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO **Ci ha incaricati di ricercare**: UN/UNA REGULATORY AFFAIRS SPECIALIST **La sede**: ROMA **Il lavoro**: - Uno _**_specialista in affari regolatori_**_ si assicura che la sua...

  • Regulatory Affairs Specialist

    4 settimane fa

    Roma, Italia Manpower srl A tempo pieno

    **Il nostro Cliente**: AZIENDA MULTINAZIONALE OPERANTE NEL SETTORE CHIMICO-FARMACEUTICO **Ci ha incaricati di ricercare**: UN/UNA REGULATORY AFFAIRS SPECIALIST **La sede**: ROMA **Il lavoro**: - Uno _**specialista in affari regolatori**_ _si assicura che la sua azienda segua rigorosamente le _**norme **_e i _**regolamenti governativi**_ _relativi agli...

  • Regulatory Affairs Specialist

    3 settimane fa

    Roma, Italia Hunters Group A tempo pieno

    2563persone hannogià visualizzato questa offerta Dettagli opportunità Settore: Funzione: Tipo di Contratto: Codice opportunità: Descrizione Per importante associazione nell’ambito elettrico italiano, che opera a tutela delle principali aziende operanti nel settore, Hunters Group è alla ricerca di una risorsa per il ruolo di Regulatory Affairs...

  • Regulatory Affairs Support

    4 giorni fa

    Roma, Italia Viatris Inc. A tempo pieno

    Regulatory Affairs Support - Internship page is loaded Regulatory Affairs Support - Internship Solicitar locations Rome, Lazio, Italy time type Tiempo parcial posted on Publicado ayer job requisition id R5646656 VIATRIS ITALIA S.R.L. En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición...

  • Regulatory Affairs Specialist

    3 settimane fa

    Roma, Italia Hunters Group A tempo pieno

    2563persone hannogià visualizzato questa offerta Dettagli opportunità Settore: Funzione: Tipo di Contratto: Codice opportunità: Descrizione Per importante associazione nell’ambito elettrico italiano, che opera a tutela delle principali aziende operanti nel settore, Hunters Group è alla ricerca di una risorsa per il ruolo di Regulatory Affairs...

  • Junior Regulatory Affairs Specialist

    2 settimane fa

    Roma, Italia ADECCO ITALIA S.p.A. A tempo pieno

    Adecco italia Spa is looking for an important client in the pharmaceutical sector a JUNIOR REGULATORY AFFAIRS SPECIALIST Basic Functions & Responsibility (may not be limited to) Be responsible for the management of the authorized products through timely submission of variations, application renewals and supplemental marketing authorizations.Carry out...

  • Regulatory Affairs Support

    6 giorni fa

    Roma, Italia Viatris A tempo pieno

    VIATRIS ITALIA S.R.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Regulatory Affairs Support

    5 giorni fa

    Roma, Italia Viatris A tempo pieno

    7092 Mylan Italia S.r.l. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless...

  • Regulatory Affairs Junior Azienda Chimico

    7 giorni fa

    Roma, Italia AXL Spa - Agenzia per il lavoro A tempo pieno

    AxL SpA - Business Unit di Roma - seleziona per azienda cliente settore Chimico-farmaceutico **ADDETTO/A AFFARI DEL REGOLATORIO - REGULATORY AFFAIRS** La risorsa, a diretto riporto del Responsabile Affari Regolatorio, seguirà l'iter di registrazione dei prodotti aziendali, predisporrà la documentazione richiesta dalle autorità e manterrà aggiornata...

  • Regulatory Affairs Specialist

    4 giorni fa

    Roma, Italia ManpowerGroup A tempo pieno

    Azienda: Manpower srl, per conto di società statunitense farmaceutica con sede a Milano, è alla ricerca di: REGULATORY AFFAIRS SPECIALIST Descrizione: Le responsabilità chiave per questo ruolo includono: - Gestione di un portafoglio prodotti comprendente procedure registrative MRP/DCP/ Nazionali oltre che prodotti parafaramaceutici. - Aggiornamento dei...

  • Government Affairs Manager

    7 giorni fa

    Roma, Italia AstraZeneca A tempo pieno

    **Government Affairs Manager** 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 **Government Affairs Manager** you will be accountable for managing the...

  • Regulatory affairs

    3 settimane fa

    Roma, Italia I.K. Hofmann A tempo pieno

    Hofmann Services ricerca per azienda Cliente: Il profilo ricercato sarà incaricato delle seguenti attività: Schede Informative del prodottoScheda sicurezza e valutazione del rischio di una materia primaAggiornamento e archiviazione materie primeStesura e controllo INCI secondo normativa vigenteControllo e approvazione impiantiSupporto regolatorio ai...

  • Junior Regulatory Affairs Specialist

    4 settimane fa

    Roma, Italia Adecco Italia Spa A tempo pieno

    Adecco italia Spa is looking for an important client in the pharmaceutical sector aINDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA Citt : Roma (Roma) Esperienza lavorativa: Regulatory affairs specialist - 12 mesi Istruzione: Laurea Magistrale Conoscenze linguistiche: Inglese - Livello Buono Competenze richieste: Word Processor - Elaborazione testi - Word, livello...

  • Technical Regulatory Associate

    4 giorni fa

    Roma, Italia Johnson & Johnson A tempo pieno

    **About Johnson & Johnson** **Laureati in Discipline Scientifiche - Technical Regulatory Associate, tempo determinato** Janssen SPA rappresenta il settore farmaceutico del gruppo Johnson & Johnson e commercializza oltre 30 specialità medicinali afferenti a cinque diverse aree terapeutiche con l'obiettivo di offrire soluzioni terapeutiche all'avanguardia...

  • Humanitarian Affairs Officer/Research Manager, P-4

    2 settimane fa

    Roma, Italia United Nations A tempo pieno

    Humanitarian Affairs Officer/ Research Manager Job Opening Job Opening ID : 230630 Job Network : Political, Peace and Humanitarian Job Family : Humanitarian Affairs Category and Level : Professional and Higher Categories , P-4 Department/Office : Office for the Coordination of Humanitarian Affairs This position is located in the Policy Branch (PB) in the...

  • Regulatory Affairs Specialist

    6 giorni fa

    Roma, Italia Viatris A tempo pieno

    3839 Viatris Pharma S.r.l. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines...

  • Regulatory Affairs Specialist

    2 giorni fa

    Roma, Italia Elettronica S.p.A. A tempo pieno

    Main Responsibilities - Management of chemical products and articles purchased and sold by the company, in compliance with European regulations. - Ensure the verification and control of the documentation relating to raw materials and CLP labeling as well as the safety data sheets of suppliers (EU/non-EU); - Provide specific analysis of the chemical risk of...

  • Regulatory Specialist, Italy

    4 settimane fa

    Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in Italy. Reporting to **Clinical Operations Manager**, you will...

  • Manager Value Access, Pricing and Health Economics

    7 giorni fa

    Roma, Italia Bristol Myers Squibb A tempo pieno

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Hta & Institutional Affairs Associate Director

    4 settimane fa

    Roma, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...