Regulatory Manager, Global Regulatory Affairs
il y a 1 semaine
Site Name:
Belgium-Wavre, GSK House, Italy - Siena
Posted Date:
Jan
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/productrelated discussions and provides indepth strategic, scientific and RA input, for clinical/labelling or procedural aspects of given project.
- Provide indepth 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 proceduralbased documents.
- Provide indepth 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) (projectspecific)
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve ontime 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
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