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Manager, Global Regulatory Affairs
4 mesi fa
**Site Name**: Italy - Siena
**Posted Date**: Jun 6 2023
**Manager, Global Regulatory Affairs**
**(maternity cover)**
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
**Job Purpose**:
Position holder (PH) will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.
The purpose of the job is to provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations; determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one specific (clinical/labelling or technical/NC or procedural) section.
**Key Responsibilities**:
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project.
- Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of given project.
- Provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects.
- Coordinate (for one specific clinical/labelling or technical/NC or procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or technical/NC or procedural sections) and ensure that those documents meet regulatory requirements.
**_ Why you? _**
**Basic Qualifications & Skills**:
- Advanced Scientific Degree (General Science or Life Science Degree)
- Experience in regulatory affairs is a plus, or appropriate relevant experience
- Broad knowledge is required and covers scientific as well as regulatory expertise
- Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred
- Fluent in English, with excellent writing skills
**Preferred Qualifications & Skills**:
- Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
- Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
- 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.
Job posting close date: 20th June
- Ricordiamo che è necessario informare il proprio responsabile nel momento in cui si viene convocati per il colloquio di selezione_
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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all l
