GlaxoSmithKline Consumer Healthcare, L.P. GRL Delegate - Shingrix in Hamilton, Montana
Site Name: Italy - Siena, Philadelphia Navy Yard, USA - California - San Francisco, USA - Maryland - Rockville, USA - Montana - Hamilton, USA - Nebraska - Lincoln, Belgium-Wavre
Posted Date: Jun 11 2021
You will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.
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 all parts of RA aspects of a given project top line and in depth on clinical/labelling or technical/NC or procedural aspects.
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 clinical/labelling or technical or procedural aspects.
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 (clinical/labelling and/or technical/NC and/or procedural) of regulatory documents, GRPs and KMSs.
May fulfil the role of N+1 review as per RSBP.
Provide input into the Global Regulatory Plan (GRP) for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections
Coordinate (for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product.
Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling and/or technical/NC and/or procedural) 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 technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy; contributes for clinical/labelling and/or technical/NC and/or procedural and accountable for one of the RA aspects.
Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and technical/NC and procedural and accountable for one or several of the RA aspects.
May 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 organisation of activities (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.
Advanced Scientific Degree
6+ years significant experience in regulatory affairs, or appropriate relevant experience.
Broad knowledge is required and covers scientific as well as regulatory expertise.
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.
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.
Fluent in English, with excellent writing skills.
Ph.D. or M.D
Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
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.
Our goalis to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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