Senior Manager, Global Regulatory Affairs

Senior Manager, Global Regulatory Affairs

GSK - GlaxoSmithKline

Wavre, Belgium

As a Senior Manager, Global Regulatory Affairs, you will have global responsibility of given activities for a Project/Product within GSK Vaccines.

The purpose of the job is to provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.

The role includes the following responsibilities:

  • You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
  • You interact with internal stakeholders and project, platform, and functional teams to provide support for technical/CMC and procedural aspects of a given project.
  • You participate to project/product-related discussions as a subject-matter expert
  • You provide in-depth strategic, scientific and RA input, for technical/CMC and procedural aspects of given project.
  • You provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
  • You coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
  • You compile/write/review high quality project/product specific regulatory documents to be submitted to Authorities for technical/CMC sections and ensure that those documents meet regulatory requirements.
  • You provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/CMC and appropriate regulatory procedures to secure the optimum submission strategy; contribute for technical/CMC and/or procedural aspects.
  • You facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for technical/CMC and/or procedural aspects
  • You 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.

Why you

Basic Qualifications:

  • Advanced Scientific Degree
  • Experience in regulatory affairs
  • 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 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.

Preferred Qualifications:

  • Ph.D. or Pharm D., Area of Specialisation: Pharmacy, Chemistry, Biology or Medicine
  • Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Belgium     Clinical Research     Manager and Executive     Regulatory Affairs     GSK - GlaxoSmithKline    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies