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Specialist Facilities

GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.

Qualifications Required

Master (Sciences, Medical Sciences or Regulatory Affairs) or Engineer, or equivalent experience on Biology, Chemistry, Biochemistry, Medical Sciences, Engineering, analytical methods and tools,
Regulatory Affairs/Quality Assurance
6+ years in pharmaceutical industry or research organization Experience of Drug
Discovery and Development, technical writing – experience of GSK Vaccine
Development would be an asset.

Qualifications requested

An Engineer/Master holder presents high level of autonomy, together with a strong scientific expertise. The job requires management of highly technical scientific matters, interactions with GSK vaccine community at large (e.g. Site Management, Manufacturing Operations, Global QA, Site QA, Site Validation, RA Product and Functional Experts etc). Combined with Regulatory Affairs expertise, this would facilitate the job main purposes i.e. the writing, review, preparation and submission of all documents relevant to support facility/equipment submission (INDs, license applications/ Life Cycle ) through close collaboration with matrix teams and site personnel for assigned projects/facilities.
Experience in regulatory requirements and management/organizational skills are needed to allow management of transversal interactions with contributing stakeholders so to obtain the necessary technical information needed for “Right the First Time” submissions....
Raphael Pèrez

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