Global Regulatory Affairs Manager, Vaccines

5 giorni fa

Siena, Italia Gsk A tempo pieno

**Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53
**Posted Date**: Oct 31 2024
**Global Regulatory Affairs Manager, Vaccines Therapeutic Group**:
Job purpose:
As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in charge of the regulatory submissions on a project perspective.
You will provide a strategic approach in a multi-disciplinary life cycle management (LCM) environment.
Please note that 2 vacancies are open. Further details will be provided during the interview stage.
In this role you will...
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to the assigned portfolio.
- Interact with (or represents his/her area/product at) internal multidisciplinary project related teams, for all parts of RA aspects of a given project top line and in depth on procedural and clinical/labelling aspects.
- Lead multidisciplinary teams
- Participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on procedural and clinical/labelling.
- Provide input into the asset specific regulatory strategy on a global scale.
- Provide support to the GRL via critical review of one or more specific sections of regulatory documents, internal and external.
- Occasionally fulfil the role of N+1 review for regulatory documents.
- Provide input into the Global Regulatory Plan for one or more specific sections
- Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Work with RA and non-RA stakeholders to ensure regulatory content is aligned with targeted overall profile of the product.
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
- Provide input to Vaccines Development Plans in order to optimize submission strategy; accountable for Procedural and Clinical RA aspects.
- Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;
- Occasionally act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s).
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL.
- Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
- Ensure planning and proper organization of activities in line with the overall project plan and RA milestones.
Why you?
- Basic Qualifications :_
- Advanced Scientific Degree ( General Science or Life Science Degree )
- Significant experience in regulatory affairs, or appropriate relevant experience.
- Experience in clinical regulatory affairs.
- Ability to lead, coordinate and execute regulatory strategy for a given project/product.
- Strategic thinker, creative mindset - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
- Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence
- Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
- Good influencing skills.
- Culturally aware.
- Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
- Ability to resolve problems through resourceful use of information and contacts.
- Enterprise thinking - needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
- Quality mindset
- Fluent in English, with excellent writing skills.
- Preferred Qualifications:_
- Ph.D. or M.D
- Previous experience in the development/ registration/lifecycle management of vaccines and obtaining licenses in different geographical areas is preferred.
**Application closing date**: Friday 15 November 2024
- Please take a copy of the Job Description, as this will not be available post closure of the advert._
LI-Hybrid
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what spe

  • Global Regulatory Affairs Manager, Vaccines

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Global Regulatory Affairs Manager, Vaccines Therapeutic Group**: Job purpose: As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in...

  • Manager, Cmc Vaccines Development Projects

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street, USA - Massachusetts - Boston, USA - Pennsylvania - Upper Providence **Posted Date**: Oct 25 2024 The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial...

  • Manager, Cmc Vaccines Development Projects

    1 settimana fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street, USA - Massachusetts - Boston, USA - Pennsylvania - Upper Providence**Posted Date**: Oct 25 2024The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle...

  • Manager, Cmc Vaccines Development Projects

    3 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena **Posted Date**: Oct 3 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work...

  • Manager, Cmc Vaccines Development Projects

    5 giorni fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: Italy - Siena**Posted Date**: Oct 3 2024We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work...

  • Vaccines Cmc Transversal Processes Lead

    3 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Rixensart, GSK HQ, Italy - Siena, USA - Pennsylvania - Upper Providence **Posted Date**: Oct 14 2024 **Job Purpose**: The Vaccines CMC Transversal Processes Lead will be responsible to diagnose, design, implement and embed enterprise continuous improvement projects within the scope of Vaccines Technical R&D (TRD) as well as maintenance...

  • Director, Pipeline Project Management

    3 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Italy - Siena **Posted Date**: Sep 25 2024 **Director, Pipeline Project Management - Vaccines**: Pipeline Project Management drives decisions and enables teams to choose the best path and deliver medicines to patients faster than ever. In GSK, the Pipeline Project Manager (PPM) will act as the...

  • Director, Pipeline Project Management

    2 settimane fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Italy - Siena**Posted Date**: Sep 25 2024**Director, Pipeline Project Management - Vaccines**:Pipeline Project Management drives decisions and enables teams to choose the best path and deliver medicines to patients faster than ever.In GSK, the Pipeline Project Manager (PPM) will act as the 'COO'...

  • Commercial Operations Italy; Key Account Manager

    7 mesi fa

    Siena, Italia Seqirus A CSL Company A tempo pieno

    The Key Account Manager position sits as part of the Commercial Operations Team Italy; this role will be working within the Triveneto region. Responsibilities include: - Develops and maintains trust relationships with key regional accounts and KOLs to increase product awareness, establishes high level scientific relationships and ensure their endorsement -...

  • Commercial Operations Italy; Key Account Manager

    1 giorno fa

    Siena, Italia Seqirus A Csl Company A tempo pieno

    The Key Account Manager position sits as part of the Commercial Operations Team Italy; this role will be working within the Triveneto region.Responsibilities include:- Develops and maintains trust relationships with key regional accounts and KOLs to increase product awareness, establishes high level scientific relationships and ensure their endorsement-...

  • Postdoc Research Associate

    2 settimane fa

    Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Italy - SienaPosted Date: Dec 16 2024Group B Streptococcus (GBS) is a major global cause of neonatal meningitis, sepsis and pneumonia, with an estimated 91,000 infant deaths per year and an additional 46,000 stillbirths. GBS infection in pregnancy is also associated with adverse maternal outcomes and preterm births. As such, the World Health...

  • Postdoc Research Associate

    2 settimane fa

    Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Italy - SienaPosted Date: Dec 16 2024Group B Streptococcus (GBS) is a major global cause of neonatal meningitis, sepsis and pneumonia, with an estimated 91,000 infant deaths per year and an additional 46,000 stillbirths. GBS infection in pregnancy is also associated with adverse maternal outcomes and preterm births. As such, the World Health...

  • Medical Writing Asset Lead

    4 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena **Posted Date**: Sep 6 2024 **_ Job purpose:_** ***: **Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.**: ***: **As a Medical Writing Asset Lead, you will lead...

  • Postdoc research associate

    2 settimane fa

    Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - SienaPosted Date: Dec 16 2024Group B Streptococcus (GBS) is a major global cause of neonatal meningitis, sepsis and pneumonia, with an estimated 91,000 infant deaths per year and an additional 46,000 stillbirths. GBS infection in pregnancy is also associated with adverse maternal outcomes and preterm births. As such, the World Health...

  • Specialista in Prevenzione

    7 mesi fa

    Siena, Italia GIGROUP A tempo pieno

    Per la BU Vaccines di GlaxoSmithKline S.P.A. ricerchiamo SPECIALISTA IN PREVENZIONE - Arezzo e Siena La/Lo Specialista in Prevenzione svolgerà attività di informazione scientifica agli MMG del territorio di riferimento, illustrando loro le caratteristiche dei Vaccini al fine di assicurarne il corretto impiego nella popolazione target. Il SIP MMG dovrà...

  • Medical Writing Asset Lead

    4 giorni fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena**Posted Date**: Sep 6 2024**_Job purpose:_*****:**Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.**:***:**As a Medical Writing Asset Lead, you will lead therapy area...

  • Specialista In Prevenzione

    1 giorno fa

    Siena, Italia Gigroup A tempo pieno

    Per la BU Vaccines di GlaxoSmithKline S.P.A. ricerchiamo SPECIALISTA IN PREVENZIONE - Arezzo e SienaLa/Lo Specialista in Prevenzione svolgerà attività di informazione scientifica agli MMG del territorio di riferimento, illustrando loro le caratteristiche dei Vaccini al fine di assicurarne il corretto impiego nella popolazione target.Il SIP MMG dovrà...

  • Store Manager

    7 mesi fa

    Siena, Italia Wyser A tempo pieno

    Per negozio di abbigliamento stiamo alla ricerca di: **Store Manager - Siena** La risorsa, a diretto riporto dell’Area Manager, avrà le seguenti responsabilità: - Orientamento e assistenza alla clientela, garantendo un elevato standard di servizio e una consulenza altamente specializzata su capi e accessori - Supervisione stock, cura del merchandising...

  • Lead, Bioassay and Sample Management

    3 mesi fa

    Siena, Italia CSL Behring A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials. As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...

  • Lead Statistician

    2 mesi fa

    Siena, Italia Gsk A tempo pieno

    Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas Posted Date: Nov 12 2024 Job Purpose Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical vaccines and medicines?...