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.

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

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.

What to Include with your Application

What to Include with your Application

Delays in receiving these documents will affect the progress of your application.
- Photo or Scanned original copy of your transcripts for all years of study. (Graduates of UL need only provide us with their Student ID number.)
- Photo or Scanned copy of passport to verify ID and full legal name.
- A copy of your most recent CV, (for Springboard+ applicants, please note that by providing this document you are agreeing that we may send it to members of industry if you require assistance when searching for an Industry Learning Placement (ILE) or project work. Applies to some courses only).

- Proof of Status, e.g. unemployed, employed, self employed, returners. Acceptable documents for proof of status can be found here https://springboardcourses.ie/eligibility
- Applicants who do not have English as their first language may satisfy English Language requirements:

If your qualifications have been obtained in a country where English is an official language this will suffice

If this is not available, the following additional documents must be provided:
• English translation of your qualification(s)/transcripts
AND
• English language competency certificate

1 year part-time Blended

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.