Regulatory Affairs Officer (Hybrid)

Malta  |  up to €25,000 

Our client is looking for a Regulatory Affairs Officer working in the pharmaceutical industry is responsible for ensuring that a company's products comply with all relevant regulatory requirements. This includes coordinating the submission of regulatory documents, such as marketing authorisation applications and post-approval variations, to regulatory agencies. Your responsibilities would include: 

  • Ensuring compliance with all relevant regulatory requirements for company products
  • Coordinating the submission of regulatory documents, such as marketing authorisation applications and post-approval variations, to regulatory agencies
  • Contributing to the continuous development and improvement of quality systems, processes and procedures
  • Managing the company's regulatory dossiers
  • Keeping up to date with changes in regulatory requirements and provide guidance to the company on how to comply with these changes
  • Negotiating with regulatory agencies to obtain approval for company products
  • Managing interactions with regulatory agencies, including responding to questions and requests for additional information
  • Participating and representing the company in regulatory activities
  • Providing training to RA officers
  • Developing regulatory strategies for new products and provide support to other departments on regulatory matters

Skill-sets and Requirements

  • Strong understanding of regulatory requirements for pharmaceutical products
  • Excellent communication and problem-solving skills
  • Strong verbal and written English and Maltese

Education & Experience

  • A Bachelor's or Master's degree in Science
  • 2 years experience in a relevant position

Job Reference: ZT370


  • Primary job focus
    Compliance
  • Job type
    Full Time
  • Employment level
    Intermediate (1-3 years)
  • Employer industry
    Pharmaceuticals
  • Languages
    English, Maltese
  • Job Reference
    ZT370
  • Closing Date
    15/02/2023
  • Date Published
    21/12/2022
  • Status
    Interviewing

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