Regulatory affairs Specialist

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On behalf of our client, an international growing global company, ruled by FDA and MMA and leader in the tailor-made production of APIs, GRS are seeking to recruit a Regulatory Affairs Specialist. This is an excellent opportunity with space for career growth for someone who possesses a Bachelor’s degree in fields such as Biochemistry, Biological Sciences, Chemistry, Pharmacy, Toxicology, Medicine, Pharmacology, or Engineering. If you have the skills and experience, please send your CV for this Malta based Regulatory Affairs Specialist Malta base role.
  • Assisting in obtaining and maintaining government approval for materials such as drugs, medical devices.
  • Responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies.
  • Responsible for executing several important duties because of continuous and constantly evolving regulations worldwide.
  • Responsible for working on the preparation of documents, management of information, maintenance of files, and coordination of tasks across multiple departments
  • Achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.
  • Understand and be familiar with all aspects of product development, which may include clinical trials, research, manufacturing practices, regulations, and approval processes.
  • Advise project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are needed in situations like labeling changes or proposed device changes.
  • Ability to work independently as well as working well within a team.
  • Proficient in English.
  • Possess and demonstrate several important skills or attributes, such as the ability to work effectively in a demanding environment, effective communication, and interpersonal skills.
  • Possess ability to pay particular attention to details, excellent organizational skills, good project management skills, proficiency, and familiarity with regulatory audits, as well as carrying out internal audits.
  • Knowledgeable in conducting quality investigations, root cause analysis and quality risk assessments.
  • Ideally, experience with the pharmaceutical industry and familiar with good manufacturing processes and FDA quality metrics.
  • Competitive salary.
  • Welcoming and inclusive environment.
  • A state-of-the-art working facility.
  • Medical check-ups.
  • Culture where teamwork is a priority.
  • A meaningful job where all employees contribute towards improving people’s lives.
  • A challenging role with an innovative company
  • Yearly medical visit
Due to the high volume of applications we receive at GRS Recruitment, only shortlisted candidates will be responded to.
To apply for this position, please email your CV to Giuseppe Buda, quoting the above job reference or call +356 2778 0664 for further information.
Job Summary
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    22 July 2022
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  • 4000
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