Regulatory Manager, Global Regulatory Affairs Brentford, England
Job description
Posted Date: Jan 18 2023
As Manager Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for Measles, Mumps, Rubella, and Varicella (MMR/V) Live Viral Vaccines lifecycle management within GSK Vaccines.
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. CRT, SRT etc.) and possibly project teams (PTs), for clinical/labelling 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 procedural aspects of given project.
Provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or procedural aspects.
Provide support to the GRL via critical review of the clinical/labelling or procedural section of regulatory documents, Global Regulatory Strategy and Global Regulatory Submission Strategy.
May fulfil the role of N+1 review for clinical/labelling or technical/NC or procedural-based documents.
Provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Strategy (GRS).
Coordinate (for one specific clinical/labelling 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 procedural sections) and ensure that those documents meet regulatory requirements.
Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or procedural aspects.
Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
Interact with regulatory counterparts in the Local Operating Companies (LOCs).
May possibly 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, within the remits of his/her expertise area (clinical/labelling and/or procedural).
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 or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
Ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.
Work in high performing matrix teams with the different GRA groups and beyond, to ensure alignment to the overall project plan and RA milestones.
Why you?
Basic Qualifications:
Advanced Scientific Degree in General Science or Life Science Degree
4+ years significant experience in regulatory affairs, or appropriate relevant experience
In line with the new organisation the focus of the Therapeutic groups is more about the overall accountability of an asset as well as on the procedural and Clinical regulatory strategies (which translates daily into managing Clinical/ labelling/ safety commitments/ license maintenance obligations, variations, Q&As, new files/ geographical expansion, authorities consultations) hence a solid experience in procedural/ registration regulatory affairs is expected and experience in clinical regulatory affairs is preferred.
Ability to coordinate and execute regulatory strategy for a given project/product.
Strategic thinker – 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.
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 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.
Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Ph.D. or M.D
Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.
Why GSK?
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 impact the health of 2.5 billion people around the world in the next 10 years.
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.
#LI-GSK
#VaccinesRD
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 specific assistance you require in order to make suitable arrangements.
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 impact the health of 2.5 billion people around the world in the next 10 years.
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 levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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