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Regulatory Affairs Assistant


Рок за пријавување:


Regulatory Affairs Assistant
Job responsibilities & duties:
  • Support the timely compilation of site documentation for global regulatory submissions.
  • Support the process of requests for legalization of GMP, ML, PoA and other documents
  • Ensure consistent and appropriate communication within the department and with other functional areas
  • Assist in the preparation for on site inspections by global regulatory authorities
  • Be open and contribute towards improvements / changing expectations
  • Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to
  • Collecting, collating and evaluating scientific data that has been researched by colleagues
  • Developing and writing clear arguments and explanations for new product licenses and license renewals
  • Preparing submissions of license variations and renewals to strict deadlines
  • Monitoring and setting timelines for license variations and renewal approvals
  • Working with specialist computer software and resources
  • Writing clear, accessible product labels and patient information leaflets
  • Planning and developing product trials and interpreting trial data
  • Advising scientists and manufacturers on regulatory requirements
  • Providing strategic advice to senior management throughout the development of a new product
  • Undertaking and managing regulatory inspections
  • Reviewing company practices and providing advice on changes to systems
  • Leasing with, and making presentations to regulatory authorities
  • Negotiating with regulatory authorities for marketing authorization; and specifying storage, labelling and packing requirements
  • Specifying storage, labeling and packing requirements.
  • Other tasks by order of the manager or director.
Required qualifications:
  • Relevant degree in Medical Sciences (Pharmacy, Biochemistry, Chemistry, Biotechnology, Medicine, Biomedical sciences etc.) Master’s in related field will be an advantage.
  • Minimum of 2 year working experience
  • Good communication skills oral and verbal in English
  • Knowledge of MS Office package
Personal profile:
  • Confident to report to management
  • Ability to work under pressure and to strict deadlines
  • Considerable understanding of both legal and scientific matters;
  • Written and oral communication skills;
  • Analytical and problem-solving skills.
We invite you if you have an interest and fit the profile for the position to send us your application with your CV, using the apply now option. 
Only the top few applicants who have previous work experience will be contacted.
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