Regulatory Affairs Manager

Reference: BE-REAFMA
Country: Belgium, Location: Around Brussels
Sector: Healthcare & Lifesciences

Job description

  • To provide support for key regulatory activities regarding a project or product.
  • To interact with internal project related teams or project teams.
  • To participate to clinical or technical or procedural aspects of project and product-related discussions and to provide strategic, scientific and RA input.
  • To provide input into the Global Regulatory Plan (GRP).
  • To coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the upper management.
  • To compile and write project and product specific regulatory documents submitted to Authorities and to ensure that the documents meet regulatory requirements.
  • To facilitate and to deliver the regulatory strategy to support the lifecycle of a product or a project.
  • To represent the point of contact for Regulatory Agencies for determined project or product.
  • To remain aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular project or product.

Profile

  • Ideally PhD or Master Degree in Pharmacy, Chemistry or Biology.
  • 4+ years significant experience in regulatory affairs, or appropriate relevant experience Project Management or Operational Excellence 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.
  • Previous experience in regulatory affairs within industry is required to ensure appropriate level of understanding of the RA activities and impact 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, maximize 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 Leader 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
  • Fluent in English, with excellent writing skills.
  • Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
  • In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
  • Fluency in English is.

 


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