Regulatory Operations Associate - career development

NonStops Client, an international pharmaceutical company based in Scotland is searching for a Regulatory Operations Associate to join the team close to Edinburgh.

Your main duty would be to support the RA team in the creation, publishing and tracking of submissions and other regulatory documents with electronic tools and specialised software.

The company is in a very stable position within the industry, with a pipeline full of new products to be developed in 2018, it is an exciting time to join and develop your skills further.
Key aspects of your new role:
* Coordinate the publishing and submission of electronic documents to regulatory authorities
* Advise and support the Regulatory team in their preparation of scientific and regulatory documents for use in electronic regulatory submissions with regard to electronic requirements and formatting
* Use and manage the electronic systems used by the Company to prepare, publish, submit and maintain regulatory submissions
* Provide appropriate training to users of these electronic systems/tools
* Support the development and implementation of procedures and processes for use of these electronic systems/tools
* Support evaluation and approval of any new release of the systems being used.
* Assist with the evaluation and implementation of document management tools, electronic publishing systems
* Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards

About you:
* Bachelor's degree (or equivalent experience) with at least 3 years Regulatory Operations and pharmaceutical industry experience required
* Experience preparing eCTD using electronic publishing system and tools, and with electronic Document Management Systems (eDMS)
* Solid knowledge of ICH guidance
* Ability and flexibility to balance multiple tasks to meet priorities and timelines
* Strong communication skills, both oral and written

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 02079402105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.