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GR
αποτελέσματα

Associate RA Manager / Senior RA Officer από την εταιρεία Pharmaceutical Company

Πλήρης Απασχόληση
Αθήνα

Περιγραφή Θέσης

Branded Generic Pharmaceutical Company with integrated spectrum of activities is seeking for 
Associate RA Manager / Senior RA Officer
Job Summary

  • Be accountable for developing regulatory strategy for the responsible projects under the guidance of line manager
  • Be accountable for the regulatory strategy implementation by regulatory submission/approval
  • Support line manager  for regulatory strategy assessment

Job required competency
1. Regulatory knowledge
  • Understands local and European regulations and guidelines
  • Understands the role and the practice of regulatory activities -Actively pursues regulatory knowledge enhancement.
  • Makes valuable contributions to the development of regulatory practices, procedures and standards
  • Manages regulatory activities across the product lifecycle

2. Drug Development and Business Knowledge
  • Understands key activities in drug development and commercialization, the role of different function areas and incorporates into regulatory activities
  • Develops internal and external network to obtain information and intelligence

3. Regulatory Strategy and Policy
  • Understands business process and involves in regulatory strategies and policies development
  • Develops and maintains current knowledge of the global, local regulatory strategy and policies
  • Understands how regulatory strategies and policies fit within the broader global and local business strategy and operations

4. Operational excellence
  • Develops regulatory strategy to achieve business excellence with the help from line manager
  • Uses internal/external resources to optimize regulatory activities

5.Leadership competency
  • Addresses and resolves conflict by creating an atmosphere of openness and trust
  • Works effectively with other people over whom he or she has no direct authority
  • Be good at promoting an idea or vision

Basic Qualification and Experience Education/Qualifications
MSc  in Pharmacy, Medical, Biology or related field

Relevant working experience:
* > 3 years’ experience in  Pharma company, at least 2 years in Regulatory

Language and PC Skills: 
  • English (proficiency level)
  • Computer skill: word, excel, power-point

The Company offers high potential of development within a European professional environment .

Κωδικός αναφοράς

RA Manager

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