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Senior Regulatory Affairs Submissions Officer

The Role:

Are you a Senior Regulatory Affairs Submissions Officer interested in working on the Regulatory Submissions team of a Generics Pharmaceutical company that is working on a global level? This company are currently the leading distributor of generic products in the Southern Hemisphere, and have a very large product portfolio. Based in an accessible location in Dublin, working in this company will give you experience working with a wide range of generic pharmaceutical products.

Day to Day:

As Senior Regulatory Affairs Submissions Officer, you will:

  • Submit the Marketing Authorisation's Applications (MAA) for assigned projects to Regulatory Authorities
  • Review all assigned regulatory submissions/MAAs for accuracy, completeness and compliance with EU regulations and relevant guidelines
  • Compile the hard copy of registration dossier and/or eCTD relevantly to specific requirements of country of registration
  • Audit the licensor's registration dossier vs. EU guidelines and specific national requirements within the in-licensing processes in order to evaluate and assess on its acceptability and identify all future possible major deficiencies

Skills/Requirements:

  • BSc in a Life Science or Pharmacy
  • 3+ year's experience in a regulatory affairs environment
  • Knowledge of EU and other regions current registration and dossier requirements

Company Culture:

Working as Senior Regulatory Affairs Submissions Officer in this global Generics Pharmaceutical Company, you will be based in a new and modern office in West Dublin. You will be welcomed in to a friendly and inclusive work environment with flexible working hours. They have a smart casual dress code and offer a slightly shorter working day on Fridays. You will join a busy team working at a fast pace on an extensive portfolio of products. The team has grown massively over the last 5 years and has plans for further expansion. You will gain a wealth of knowledge and experience working with a large and supportive team in a company that has a clear progression path.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales