Senior Manager Global Regulatory Affairs - Saint-Amand-les-Eaux, France - GSK

GSK
GSK
Entreprise vérifiée
Saint-Amand-les-Eaux, France

il y a 3 semaines

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Site Name:
Belgium-Wavre, France - Rueil Malmaison, GSK House, Italy - Siena, Rockville Vaccines, Saint-Amand-les-Eaux


Posted Date:
Mar


As Senior Manager, Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for
RSV OA (regional) within GSK Vaccines.



  • Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines 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 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 or more specific section(s).
  • Lead multidisciplinary team focusing on meeting/delivering specific regulatory milestones/ documents (eg, briefing documents for agencies consultations, Paediatric Investigation Plan, IND, CTA, ).
  • Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.).
  • Provide regulatory input for one or more specific sections of certain/all development stages of the project/product within a given product portfolio.
  • Ensure, from an RA perspective, the execution of the product development/ lifecycle regulatory strategy in order to ensure a complete and rapid development/lifecycle of the asset.
  • Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
  • May act as lead or N+1 within the project, being accountable for the overall delivery of projectrelated activities, in collaboration with the members of the team.

Key responsibilities:


  • Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to the assigned portfolio.
  • Interact with (or represents his/her area/product at) internal multidisciplinary project related teams, for all parts of RA aspects of a given project top line and in depth on procedural and clinical/labelling aspects.
  • Lead multidisciplinary teams
  • Participate to project/productrelated discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on procedural and clinical/labelling.
  • 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 of regulatory documents, internal and external.
  • May fulfil the role of N+1 review for regulatory documents.
  • Provide input into the Global Regulatory Plan for one or more specific sections
  • Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
  • Work with RA and nonRA stakeholders to ensure regulatory content is aligned with targeted overall profile of the product.
  • Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
  • Provide input to Vaccines Development Plans in order to optimise submission strategy; accountable for Procedural and Clinical RA aspects.
  • Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;
  • May 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.
  • 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 in line with the overall project plan and RA milestones.

_ Why you?_:


Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Advanced Scientific Degree in General Science or Life Science Degree
  • Experience in the lifecycle management of vaccines, obtaining and maintaining licenses in different geographical areas
  • Solid experience in procedural/ registration and clinical regulatory affairs.
  • Ability to lead, coordinate and
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