MSc in Pharmaceutical Regulatory Affairs

Key points

  • Work permit while you study

  • Post Graduation Work Permit for 24 months

  • Starting dates: September

  • Duration: 1 year

  • Level 9 Qualification

  • Type: Full Time
  • Hours: Daytime
  • Enrollment Fee: From € 11,250 / year

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The program enables existing regulatory affairs personnel in the pharmaceutical regulatory industry to understand all current diagnostic and medical device regulations and develop the skills necessary to work successfully in the dynamic world of regulatory affairs. The program will also allow the graduate to develop a transferable skill set to directly meet the requirements of a wide range of future employers, including information technology, verbal and written communication skills, teamwork, research skills. independent, data analysis and critical thinking. Instruction will include traditional lectures supported and complemented by a managed learning environment that incorporates elearning, discussion forums, and moderated online discussions.

Special features

Opportunities for graduates of this program include progression to level 10 (Ph.D.) programs in related fields of study.

According to a report by the Forfás Expert Group on Future Skills Needs, Ireland is emerging as a leading location for biopharmaceuticals with a mix of startups, high-growth SMEs and large multinationals located here.

Industry leaders, including Pfizer, Eli Lilly, Sanofi, MSD (Carlow based biologics) and Alkermes plc, have significant investment in Ireland that has facilitated the rapid growth and development of the industry.

These, along with a strong generics industry (Wockhardt, Clonmel Healthcare, both based in the Southeast) provide prospective employment opportunities for graduates and key engagement partners for the course.

There are currently approximately 60 biopharmaceutical companies in Ireland employing around 4,000 people. This program is designed to meet the growing demand for scientists to serve current and emerging biotechnology-based industries in Ireland, in particular the South East, the Middle East and the Midlands. The current industry perception is that Ireland’s future technology will be based primarily on biotech and IT oriented industries.

Professional oportunities

Our graduates work in areas such as Electronic Product Design, Electrical Services, Electrical Engineering, Control and Automation and Communications.

A sampling of our graduate destinations includes:

  • ABB
  • Agilent Technologies
  • Amazon Web Services
  • Anord Mardix
  • Analog Devices
  • Blueacre Technology
  • CombiLift
  • ControlSoft Automation
  • ESB International
  • Electricity Supply Board
  • Facebook
  • Glen Dimplex Renewables
  • Hanley Energy
  • Hewlett Packard
  • Intel
  • Mercury Engineering
  • Nikon Precision Europe
  • NXP Semiconductors
  • Realtime Technologies

Program structure

  • Life cycle management, surveillance, surveillance and risk management
  • Pharmaceutical technology regulatory affairs
  • Clinical and non-clinical evaluation of pharmaceutical technologies
  • Principles of drug discovery and development planning
  • Research methods and writing technical reports
  • Special populations and biological and advanced therapies
  • Dissertation

Admission requirements

A Bachelor’s degree in science, engineering, quality, pharmaceutical or regulatory affairs or related areas.

Candidates with significant experience in: pharmaceutical operations, quality engineering, device design, middle to senior management in industry, other professionals who want to improve in the regulatory affairs environment, regulatory affairs staff who want to improve (as determined by the Prior Learning Policy Institute recognition), in addition to an elementary honors degree in another discipline area may also be considered for entry.

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