Senior Associate, Regulatory Operations - Publishing

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United Kingdom
London
Posting date: 09 Aug 2019
RA.NS.24723_1565345191

A leading biotechnology company is seeking to recruit a Senior Associate, Regulatory Operations - Publishing to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.

Job Responsibilities:

  • Formatting, publishing, transmitting, and archive all submission types.
  • Planning, publishing (eCTD), reviewing and delivery of lifecycle submissions to Health Authorities within required timelines.
  • Answering technical questions for many submission types.
  • Attend Regulatory Submission team meetings, and act as the publishing SME on behalf of the Regulatory Operations function.
  • Able to answer technical questions for many submission types. Able to troubleshoot and resolve issues with critical computer application systems, e.g., MS Word, Adobe and InSight Publisher.

Skills and Requirements:

  • Formatting, publishing, transmitting, and archive all submission types.
  • Planning, publishing (eCTD), reviewing and delivery of lifecycle submissions to Health Authorities within required timelines.
  • Answering technical questions for many submission types.
  • Attend Regulatory Submission team meetings, and act as the publishing SME on behalf of the Regulatory Operations function.
  • Able to answer technical questions for many submission types. Able to troubleshoot and resolve issues with critical computer application systems, e.g., MS Word, Adobe and InSight Publisher.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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