About the job

We are looking for a Regulatory Affairs Associate to support the team on incoming new projects.

About us

Group 10
Responsibilities

  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Document and track regulatory submissions and regulatory authority approval inside document management systems
  • Provide regulatory support to clients and associate companies.
  • Liaise with external regulatory authorities as required.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check).
  • Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
  • Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)

Group 11
Education

University background and/or experience in Regulatory affairs.

Bachelor’s degree in a science related field, or A levels with data entry experience.

Group 12
Experience

0-1 year RA experience

Group 13
Skills

  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Process oriented with good attention to detail
  • Effective oral and written communication skills
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Fluent German mandatory along with fluent English

 

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