Regulatory Affairs - Bio - Pharmacheuticals

This Professional Diploma is available to graduates with a background in quality, manufacturing, pharmaceutical, bio-pharmaceutical or chemical sectors. It is for those with an interest in organisational improvement and development through the use of Regulatory Affairs tools and techniques. Students will gain an understanding of both theory and practical application of RA tools and techniques to improve operational outcomes and efficiency. Graduates will learn about EU regulatory requirements, as well as the main features of the regulatory system in the US, which is the most important other jurisdiction for RA professionals based in Ireland. Graduates of this course will gain a Level 9 Professional Diploma in regulatory affairs which can build towards a MSc in Engineering Practice.

Key Facts
Brexit means that more Irish based pharmaceutical companies are managing biopharma regulation in house, resulting in increased job opportunities in the field.

Entry requirements

Programme participants should hold a NFQ level-8, primary honours degree or an equivalent qualification and have at least five years of relevant work experience. Where an applicant does not meet the entry requirements above, they can be evaluated under the UL RPL (prior learning) policy and may be interviewed to ascertain their suitability for the programme.

Subjects taught

Semester 1
• Drug Regulation and the Agencies

• Regulatory Affairs Interactions in Drug Development and Product Marketing

• Key Regulatory Considerations for Non-Clinical and Clinical Development and Clinical Operations

Semester 2
• Regulatory Requirements for a New Active Substance: Chemical and Pharmaceutical

• Regulatory Strategy and Requirements for Established Active Substances

Duration

1 year part-time Blended

Post Course Info

Career Development

Industry Presentations on Current Activity in Ireland and Future Potential in the sector

Employer Open Days

Presentation Skills Workshops

CV Preparation

Confidence, Motivation & Job Readiness Workshops

* The number of in-company work placements offered depends on the student's location, topic area and motivation to participate in all elements of the course. A work placement manager will work with participants and companies to find the best fit but the onus is on the learner to play an active role in this process.

More details
  • Qualifications

    Minor Diploma (Level 9 NFQ)

  • Attendance type

    Part time,Morning,Daytime,Blended

  • Apply to

    Course provider