Senior Regulatory Affairs Consultant – Maas Global Acceleration Initiative

2 mesi fa

Bardi, Italia Buscojobs A tempo pieno

Senior Regulatory Affairs Consultant – MAAs Global Acceleration InitiativeParexel
When our values align, there's no limit to what we can achieve.
We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets.
This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets.
Our global regulatory teams are well supported to prioritise our major markets filings and are targeting high quality simultaneous filings with Stringent Regulatory Authorities (SRAs) as well as rest of world markets.
Our ambition is to accelerate the time for submission, approvals and accessing markets, and this role's mission will be to help realise this ambition.
Key Responsibilities: Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions.Identify risks and mitigations to protect business interests and maintain timelines.Lead detailed preparation of regulatory plans for individual country filings.Lead global filing teams in generating country-specific datasets and updating core documentation.Lead adaptation of core dossier contents for country submissions.Coordinate filing teams for RTQ generation, provide strategic guidance to the global filing teams to address the regulators' questions and guide the team to prepare high quality responses.Set up global filing team meetings, draft responses, coordinate reviews and approvals.Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities.Work closely with the local and regional regulatory leads on all aspects of marketing review and approvals.Manage routine MA maintenance activities as required.Qualifications and Experience: University degree in a life science industry.8-15 years of relevant regulatory affairs experience.Extensive experience in preparing global filing plans for markets worldwide, and awareness of regulatory frameworks in all major markets globally.Strong leadership skills and motivated, to support senior filing teams through marketing applications, overarching CMC, Clinical and Nonclinical.Familiarity with CPPs and timing for filings in various markets.Proficiency in Veeva Vault and other regulatory systems.Excellent communication and organizational skills.Experience working within a regulatory matrix team in the pharmaceutical industry.
#J-18808-Ljbffr

  • Senior Regulatory Affairs Consultant

    2 mesi fa

    Bardi, Italia Buscojobs A tempo pieno

    Senior Regulatory Affairs Consultant – MAAs Global Acceleration Initiative Parexel When our values align, there's no limit to what we can achieve. We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to...

  • Senior Regulatory Affairs Manager

    1 mese fa

    Bardi, Italia Buscojobs A tempo pieno

    When our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager / Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a...

  • Senior Regulatory Affairs Specialist

    3 mesi fa

    Bardi, Italia Page Personnel A tempo pieno

    Ricerchiamo un profilo specializzato in ambito Regulatory Affairs nell'ambito dei principi attivi farmaceutici che, a riporto del Regulatory Affairs Manager, andrà ad occuparsi di gestione, aggiornamento e sottomissione puntuale della documentazione regolatoria dei prodotti nel portafoglio aziendale.Supporto ai vari dipartimenti aziendali e agli stakeholder...

  • Regulatory Affairs Specialist

    5 giorni fa

    Bardi, Italia Pharma D&S A tempo pieno

    Pharma D&S ricerca un Regulatory Affairs Consultant con almeno due anni di esperienza nel ruolo.La risorsa selezionata si occuperà di:- Gestione della sottomissione regolatoria e valutazione dei dati tecnici di tutte le procedure regolatorie- Preparazione e manutenzione di Dossier Regolatori- Variazioni e procedure di rinnovo- Variazioni di AIC e di Safety...

  • Regulatory Affairs Consultant

    3 giorni fa

    Bardi, Italia Pharma D&S A tempo pieno

    Pharma D&Sricerca un Regulatory Affairs Consultant - Medical Devices con esperienza di 1 o 2 maturata nel settore regolatorio dei dispositivi medici.La risorsa selezionata si occuperà di:Redazione, aggiornamento e gestione delle modifiche ai fascicoli tecnici dei dispositivi medici, in accordo al nuovo MDR 2017/745.Redazion e e aggiornamento di documenti...

  • Regulatory Affairs

    3 giorni fa

    Bardi, Italia Page Personnel A tempo pieno

    Regulatory affairs- Azienda chimico farmaceutica**Il nostro cliente**:Azienda chimico farmaceutica situata in zona Como**Ruolo**:La risorsa, rispondendo al manager di dovra' occupare di:- stesura e aggiornamento dei Drug Master Files e della preparazione della documentazione regolatoria destinata ai Ministeri della Sanità Nazionali ed Internazionali.-...

  • Regulatory Affairs Head

    3 settimane fa

    Bardi, Italia Adh Personal Thüringen A tempo pieno

    We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head.Key Responsibilities:Lead and manage the Regulatory Affairs team, ensuring proper training and professional development.Supervise the preparation, updates, and submission of European and international regulatory dossiers.Define...

  • Regulatory Affairs Head

    2 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    5 giorni faWe are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head.Key Responsibilities:Lead and manage the Regulatory Affairs team, ensuring proper training and professional development.Supervise the preparation, updates, and submission of European and international regulatory...

  • Regulatory Affairs Head

    3 settimane fa

    Bardi, Italia Adh Personal Thüringen A tempo pieno

    We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head.Key Responsibilities:Lead and manage the Regulatory Affairs team, ensuring proper training and professional development.Supervise the preparation, updates, and submission of European and international regulatory dossiers.Define...

  • Regulatory Affairs Head

    3 settimane fa

    Bardi, Italia Adh Personal Thüringen A tempo pieno

    We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head. Key Responsibilities: Lead and manage the Regulatory Affairs team, ensuring proper training and professional development. Supervise the preparation, updates, and submission of European and international regulatory dossiers....

  • Regulatory Affairs Head

    2 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    5 giorni fa We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head. Key Responsibilities: Lead and manage the Regulatory Affairs team, ensuring proper training and professional development. Supervise the preparation, updates, and submission of European and international regulatory...

  • Regulatory Affairs Manager

    2 mesi fa

    Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pieno

    Regulatory Affairs Manager (m/w/d)Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.TasksObtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.Compile Global Registration File...

  • Regulatory Affairs Manager

    4 settimane fa

    Bardi, Italia Ch01 Che Fresenius Medical Care Ag A tempo pieno

    Regulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy. Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap. Compile Global Registration...

  • Regulatory Affairs Intern

    2 settimane fa

    Bardi, Italia Pharma D&S A tempo pieno

    **Stage in Regulatory Affairs**Pharma D&S ricerca neolaureati/e in discipline scientifiche per l'attivazione di un percorso di stage nel Regulatory Affairs.Le risorse selezionate verranno affiancate al Team RA e avranno modo di:- Approfondire la conoscenza del quadro normativo nazionale e internazionale- Collaborare alla preparazione della documentazione...

  • Regulatory Affairs Manager

    2 mesi fa

    Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pieno

    Regulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.Compile Global Registration File...

  • Regulatory Affairs Manager

    2 mesi fa

    Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pieno

    Regulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap. Compile Global Registration...

  • Regulatory Affairs Specialist

    5 giorni fa

    Bardi, Italia Multichem R&D A tempo pieno

    Regulatory Affairs and Quality AssuranceAzienda Chimica specializzata nella ricerca e sviluppo nel campo della Green Chemistry, presente sul territorio di Milano Sud dal 2000, ricerca un* Regulatory Affairs and Quality Assurance Specialist che abbia maturato esperienza nel settore della cosmetica, nelle registrazioni prodotti su portali istituzionali e...

  • Regulatory Affairs Intern

    5 giorni fa

    Bardi, Italia Art Cosmetics S.R.L. A tempo pieno

    We are Art Cosmetics, an Italian B2B contract manufacturer specialized in color cosmetics.We're one of the leading firms in the famous Italian Cosmetic Valley, the golden triangle between Milan, Bergamo and Crema.Our role on the global market is to deliver innovation, supporting our creativity with sound technical and scientific expertise.Would you like to...

  • Regulatory Affairs Specialist

    2 settimane fa

    Bardi, Italia Art Cosmetics S.R.L. A tempo pieno

    We are Art Cosmetics, an Italian B2B contract manufacturer specialized in color cosmetics. We're one of the leading firms in the famous Italian Cosmetic Valley, the golden triangle between Milan, Bergamo and Crema. Our role on the global market is to deliver innovation, supporting our creativity with sound technical and scientific expertise.**Posizione**:In...

  • Regulatory Affairs Specialist

    3 mesi fa

    Bardi, Italia In Job S.P.A. A tempo pieno

    In Job S.p.A. – Milan's Career Center is hiring a   Regulatory Affairs Specialist   for a lead company in the pharmaceutical industry.  KEY RESPONSIBILITIES Support product development and manage registration and maintenance of new and/or existing products worldwide; Assist in updating and maintaining the Regulatory Information Management System (RIMS);...