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 practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

**In this role, you will **
- Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities;
- Work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy;
- Ensure regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions;

**_ Why you?_**:
**Basic Qualifications & Skills**:
We are looking for professionals with these required skills to achieve our goals:

- Master’s Degree in Life sciences or related scientific discipline Regulatory Affairs Certification (RAPS)
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
- Sound knowledge of drug development, manufacturing processes and quality control and may have a specialized area of expertise.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Fluency in English (written and spoken)

Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

- Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
- Strong interpersonal, presentation and communication skills with established internal networks
- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
- Demonstrated ability to handle global CMC issues through continuous change and improvement
- Previous experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development.)

**Closing Date for Applications - October 17th, 2024**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

**Important notice

  • Manager, Cmc Vaccines Development Projects

    3 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

    2 settimane 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

    2 settimane 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...

  • Vaccines Cmc Transversal Processes Lead

    15 ore 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 of...

  • Director, Vaccine Mature Products, Cmc

    3 giorni fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena, Belgium-Wavre, UK - London - New Oxford Street, USA - North Carolina - Durham **Posted Date**: Jan 7 2025 **Director, Vaccine Mature Products, CMC**:** Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland** Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle...

  • Director, Vaccine Mature Products, Cmc

    15 ore fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: Italy - Siena, Belgium-Wavre, UK - London - New Oxford Street, USA - North Carolina - Durham**Posted Date**: Jan 7 2025**Director, Vaccine Mature Products, CMC**:** Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland**Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management...

  • Director, Vaccine Mature Products, CMC

    7 ore fa

    Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMCLocation: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, PolandDirects key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...

  • 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...

  • Global Regulatory Affairs Manager, Vaccines

    2 settimane 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...

  • Director, Pipeline Project Management

    4 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

    3 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'...

  • Quality Business Partner

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - Hertfordshire - Stevenage **Posted Date**: Nov 7 2024 **Quality Business Partner - Development**:** Location**:GSK HQ/Stevenage (UK), US The purpose of the role is to be the quality advocate for their given area of responsibility. The Quality...

  • Postdoc Research Associate

    3 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

    3 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...

  • Stage Business Analysis And Projects Support Supply

    2 settimane fa

    Siena, Italia Circle Group A tempo pieno

    Lavorare nel Gruppo Circle ti consentirà di partecipare a progetti innovativi e coinvolgenti, in un'organizzazione con team fluidi e agili, focalizzati su obiettivi condivisi.**Ricerchiamo persone appassionate che vogliono unirsi a noi e alle quali offriamo**:- _Valorizzazione delle competenze_- _Condivisione delle conoscenze_- _Opportunità di...

  • Quality Business Partner

    5 giorni fa

    Siena, Italia Gsk A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - Hertfordshire - Stevenage**Posted Date**: Nov 7 2024**Quality Business Partner - Development**:** Location**:GSK HQ/Stevenage (UK), USThe purpose of the role is to be the quality advocate for their given area of responsibility.The Quality Business...

  • Postdoc research associate

    3 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...

  • Strategic Portfolio Development Consultant

    3 giorni fa

    Siena, Toscana, Italia Motorola Solutions. A tempo pieno

    Unlock Business Growth with Innovative Product SolutionsAt Motorola Solutions, we are committed to helping individuals and organizations achieve their full potential. As a Strategic Portfolio Development Consultant, you will play a pivotal role in shaping the future of our products and solutions.About the RoleThis is an exciting opportunity for a seasoned...

  • 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...