Regulatory Affair Associate

  • Full-time
  • Department: Clinical Delivery

Company Description

Ergomed is a rapidly growing  global clinical research company.  Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in executing complex trials for  new Rare Disease, Oncology and Neuroscience treatments.

Ergomed Plc is a public company on the London stock exchange.

The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

This is a junior role where you will have the opportunity to work with an international team and to take your first step towards a career in Regulatory Affairs and Start-Up. You will gain valuable working experience and develop skills needed throughout your career including teamwork, problem solving and communication skills.

As a RA Associate/Assistant you will be providing administrative support to the team in submitting Clinical Trial Applications to Regulatory Authorities and Ethics Committees around the world. Duties included:

  • Assist in the preparation and collection of regulatory documents for submission of initial Clinical Trial Applications and amendments to national competent authorities and ethic committees.
  •  Assists with the coordination and review of translations of regulatory correspondence and various documents required for submission
  • Ensure on time signing, printing and dispatch of documents up to delivery confirmation. 
  • Perform administrative quality control checks (QC) of submission dossiers. 
  • Arrange payments to Ethics Committees and Regulatory Authorities. 
  • Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
  • Ensure time filing of documents into the relevant repository platforms (i.e. Flex database)
  • Assist department members with project and no-project administrative tasks, such as collection, completion and tracking of documents/information (i.e. forms, reports, correspondence logs, CVs, job descriptions, training records, contact details, etc.)

 

Qualifications

Degree in Chemistry or Life Sciences, Nursing or equivalent experience preferred but not essential.

Additional Information

Our Offer

  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings
  • Friendly working environment with several social events per year
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