QUALIFICATION FILE_LFS_Q0501_Ver1.01.pdf

Drug Regulatory Affairs Chemist

  • Job DescriptionDRA Chemists are responsible for making dossiers submitted to the various markets and also ensue completion for forms and carry out filling of regulatory forms.
  • CodeLFS/ Q 0501
  • SectorLife Sciences
  • NSQF LevelLevel 5
  • Notional Hours300
  • Accrediting BodiesLife Sciences Sector Skills Council
  • Certifying BodiesLife Sciences Sector Skills Council
  • Proposed Occupation

    Drug Regulatory Affairs Chemist is also known as Dossier Associate falls under Research & Development Occupation. The individual is responsible for making dossiers submitted to regulatory bodies for the various markets and also ensue completion for forms and carry out filling of regulatory forms. The job requires individual to apply knoweldge of life sciences. industry. knowledge of organic chemistry and regulatory affairs and golabl regulatory requirements. and documentation practices. The individual uses the skills like critical and analytical thinking. problem solving. decision making. planning and organizing and communcation skills. The individual is responsible for his/ her work and learning and has some responsibility for other cross functional colleagues work and learning.

  • International Comparability

    While preparing the NOSs, a detailed secondary desk research was conducted. The European, South African and Australian NOSs were referred to. The relevant International NOSs for the job role are listed below for reference: UK NOS . SFHPHARM23 check documentation and materials . COGLS2 Maintain effective and efficient working relationships . COGPIO3.2 control emergencies . COGLS201 Follow health and safety procedures in life sciences . COGLS301 Maintain health and safety in life sciences Switzerland NOS - Australia NOS . Communicate workplace information . Participate in work teams and groups South Africa NOS . Apply the principles of asepsis and sterility in a healthcare environment . Act in accordance with ethical and legal codes of pharmaceutical representation and the laws of the country

  • Progression Pathway

    Upward progression: Manager- Drug Regulatory Affairs Lateral/ Horizontal progression: Regulatory Affairs Associate

  • Qualification File QUALIFICATION FILE_LFS_Q0501_Ver1.01.pdf
  • Supporting Documents
  • Formal structure of the qualification
    Title of unit or other component Mandatory/ Optional Estimated size (Hours) Level
    LFS/N0501 To ensure appropriate licensing marketing and legal compliance of pharmaceutical and medical products Mandatory 100 Level 5
    LFS/N0503 To ensure that the products comply with the regulations Mandatory 50 Level 5
    LFS/N0502 To carryout reporting and documentation for dossier preparation Mandatory 100 Level 5
    LFS/N0105: To coordinate with manager and team members for smooth functioning Mandatory 50 Level 5