Regulatory Affairs Manager

Malta

Our client, an international pharmaceutical company that is expanding locally, is recruiting for a Regulatory Affairs Manager. Whilst reporting to the Quality Assurance Manager, your duties will include;

  • Preparing and submitting the Drug Master File (DMFs) including DCPs to clients and health authorities, respecting timelines all the time
  • Handling Deficiency Letters raised by FDA, health authorities and clients
  • Assisting clients by preparing the Applicant Parts (Regulatory Dossier), and the access letters for the registration of drugs
  • Proposing improvement in the management process within his/her competence (ICH Guidelines, FDA, Law, etc.)
  • Handling eCTD software and other e-platform for submission of Regulatory Documents in various Regulatory Agencies
  • Ensuring the Regulatory Compliance across the manufacturing site
  • Reviewing change controls for their impact on the respective Regulatory submissions
  • Interacting with all customers regarding various Regulatory issues related to submission of Applicants Part of Active substance Master Files (ASMFs)
  • Preparing and reviewing SOPs related to regulatory affairs

Skill-sets and Requirements

  • Previous experience within a Quality / Regulatory role in Pharmaceuticals is required
  • Clear proficiency in leading initiatives which impact regulatory decision-making
  • Excellent verbal and written communication skills in English

Education & Experience

A diploma / Degree level of education within a scientific field is required

Job Reference: NR665


  • Primary job focus
    Quality Control
  • Job type
    Full Time
  • Employment level
    Experienced (3 years +)
  • Employer industry
    Healthcare, Pharmaceuticals
  • Languages
    English
  • Job Reference
    NR665
  • Closing Date
    30/09/2022
  • Date Published
    04/03/2022
  • Status
    Shortlisting

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