QA Regulatory Affairs Specialist (80-100%)

Ferring Pharmaceuticals A/S

Fuldtidsjob
Udlandet (øvrige)

Role :
Interfacing between development and operations, qualification/validation, QC, QA and Global Regulatory Affairs and Affiliates, you will be responsible for managing change control activities for the Ferring Swiss Manufacturing Plant (FSMP) and contribute to the pharmaceutical Regulatory Affairs activities linked to the plant.

Main responsibilities :

  • Manage change control activities for the plant (continuous improvement of change management system, change control committee organisation, procedure writing, training, monthly indicators, follow respect of procedure, etc.)
  • Support QA teams to manage and review change records and assess their regulatory impact
  • Maintain currency and consistency of regulatory documentation managed by plant QA regulatory team in several regulatory databases
  • Answer technical questions raised by Global Regulatory Affairs, affiliates and regulatory agencies during product registration procedures (new applications, variations, renewals, annual reports, commitments, tenders)
  • Support QA regulatory team to prepare, update and review Common Technical Documents (CTD) Module 2/Module 3 quality documents

Required Experience & Competences :

  • Scientific degree (pharmacy, chemistry, biology or equivalent)
  • Experience in the pharmaceutical industry and GMP environment (5 years’ experience)
  • Experience in Regulatory Affairs, writing CTD Module 2/Module 3 documents and answering questions from health authorities would be a plus
  • Experience in analytical methods, quality control would be a plus
  • Worldwide environment: EU, US, China, Japan, LatAm, META
  • Attentive to details, rigorous, analytical skills
  • Autonomous, well-organised and able to handle several tasks simultaneously and with high accuracy, ability to synthesize
  • Capability to work under pressure in a complex matrix organization and demanding business networking
  • Customer- and solution-oriented
  • Good team player with excellent interpersonal skills, positive thinking, enthusiasm and commitment
  • Fluent in English and French
  • Solid skills in Microsoft Office; Experience in Trackwise

Location:

Switzerland SMP - St Prex


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Fuldtidsjob
Udlandet (øvrige)
Kemi, Biotek & Materialer
Medicinal & Sundhed
Naturvidenskab
Teknik & Teknologi
Data & analyse
Forskning & Udvikling
Ledelse & Planlægning
Medicinal & Sundhed
Naturvidenskab
Produktion
Teknik



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https://jobbank.dk/job/1477587/