Master’s in Regulatory Engineering and Regulatory Affairs
Online master's programme of 1,900 hours in regulatory engineering and regulatory affairs. 12 modules covering the EU medicines framework, CTD and eCTD dossiers, clinical trials, ICH guidelines, medical devices and IVDs, pharmacovigilance, GMP, international markets, life-cycle variations and regulatory innovation, with an assigned technical tutor.
Master’s in Regulatory Engineering and Regulatory Affairs — studying from Australia
Health technology and biomechanics are growing areas in Australia, supported by a strong medical research sector and an established medical device industry. Wearable devices and occupational safety systems are increasingly used in mining, construction and healthcare. Medical devices are regulated nationally, requiring engineers to understand conformity, risk management and clinical evaluation. Employers include medical device manufacturers, hospitals, research institutes such as those affiliated with universities, and workplace safety consultancies.
Fees for Australia: A$11,000 (AUD), with instalments and employer sponsorship available.
Relevant bodies in Australia
Typical roles
Questions from Australia
Will a SEIUM qualification be recognised by Engineers Australia or other professional bodies for this area?
SEIUM qualifications are private qualifications and are not accredited by Engineers Australia or any other national body. Recognition is decided by individual employers and, where relevant, by the professional body assessing your application. Engineers Australia assesses skills and experience independently, so check directly with the body you hope to join before enrolling.
Which Australian employers might value this training in health, biomechanics or wearable safety work?
Employers in Australian medical device firms, rehabilitation services, workplace health and safety teams and wearable technology companies may consider advanced engineering training when hiring. Whether they value a private qualification depends on each employer's own policy and on your existing experience. Speaking with prospective employers about how they view private qualifications is a sensible step.
Can I study this alongside full-time work in Australia, and is employer funding possible?
The programmes are 100% online and taught in English, so you can study from any time zone, including Australian time zones, around your work hours. Fees are payable in instalments, and employer sponsorship is possible; ask your employer whether they fund training. Plan for the workload of 300 to 1,900 hours depending on the programme, and confirm the schedule with SEIUM.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Interpret the European regulatory framework for medicines and medical devices.
Choose the appropriate authorisation procedure for each product.
Build the structure of a CTD dossier in eCTD format.
Manage clinical trial applications under Regulation (EU) 536/2014.
Apply the ICH quality, safety and efficacy guidelines.
Organise pharmacovigilance and medical device vigilance systems.
Design global and life-cycle regulatory strategies.
Who it's for
- Regulatory affairs officers.
- Pharmacovigilance managers.
- International registration specialists.
- Regulatory consultants.
- Clinical trial managers.
- Pharmaceutical quality managers.
- Engineering or science graduates looking to enter the pharmaceutical industry.
What you'll work with
- Directive 2001/83/EC (Community code relating to medicinal products for human use)
- Regulation (EC) 726/2004 (centralised procedure)
- Regulation (EU) 536/2014 (clinical trials)
- Regulation (EU) 2017/745 (medical devices)
- ICH E6 (good clinical practice)
- ICH M4 (Common Technical Document)
- Regulation (EC) 1234/2008 (variations)
- Royal Legislative Decree 1/2015 (Spanish consolidated law on guarantees for medicines)
- Veeva Vault RIM
- Lorenz docuBridge
- EudraVigilance
- CTIS
- Microsoft Project
12 modules · 1900 h
1.1The role of regulatory affairs within the company1.2Agencies: EMA, AEMPS, FDA and PMDA1.3Medicines, medical devices and combination products1.4Regulatory life cycle of the product1.5Regulatory intelligence and monitoring1.6Regulatory ethics and transparency1.7Relations with authorities1.8Competencies of the regulatory professional1.9Organisation of a regulatory department1.10Case study: regulatory map of an innovative product
2.1Directive 2001/83/EC and the Community code2.2Regulation (EC) 726/2004 and the centralised procedure2.3Decentralised and mutual recognition procedures2.4Royal Legislative Decree 1/2015 in Spain2.5The CHMP and PRAC committees2.6Orphan and paediatric medicines2.7Biosimilars and generics2.8Revision of the EU pharmaceutical legislation2.9Pricing and reimbursement2.10Practical exercise: choosing the authorisation procedure
3.1Structure of the five modules3.2Module 3: quality3.3Modules 4 and 5: non-clinical and clinical3.4Module 2 summaries3.5eCTD 4.0 electronic format3.6Regulatory document management3.7Summary of product characteristics and package leaflet3.8EMA QRD templates3.9Technical validation of the submission3.10Workshop: index of an eCTD dossier
4.1Regulation (EU) 536/2014 and authorisation4.2The CTIS portal and how it works4.3ICH E6 good clinical practice4.4Research ethics committees4.5Protocols and amendments4.6Safety in trials and SUSARs4.7Transparency and publication of results4.8Decentralised elements in clinical trials4.9Post-authorisation observational studies (PAS)4.10Practical exercise: simulated application in CTIS
5.1Architecture of the ICH guidelines5.2Quality: ICH Q8, Q9 and Q105.3Stability under ICH Q15.4Impurities under ICH Q35.5Non-clinical safety: ICH S series5.6Clinical efficacy: ICH E series5.7Multidisciplinary guidelines and M45.8Q12 and life-cycle management5.9Implementation in practice5.10Case study: stability strategy for a new product
6.1Regulation (EU) 2017/745 and its application6.2Regulation (EU) 2017/746 and its transition6.3Classification and notified bodies6.4Technical file and EU declaration of conformity6.5Clinical and performance evaluation6.6Vigilance and EUDAMED6.7Person responsible for regulatory compliance6.8Differences from the FDA6.9Software and Rule 116.10Practical exercise: regulatory pathway for a diagnostic test
7.1Good pharmacovigilance practices (GVP)7.2Adverse reaction reporting7.3Case management in EudraVigilance7.4Periodic safety update reports (PSUR)7.5Risk management plan7.6Signal detection7.7Qualified person for pharmacovigilance7.8Audits and inspections7.9Additional risk minimisation measures7.10Laboratory: assessment of a safety signal
8.1EU GMP rules8.2Annex 1 on sterile manufacturing8.3Good distribution practice (GDP)8.4Qualified person and batch release8.5ALCOA+ data integrity in GMP8.6Computerised system validation8.7Inspections and non-conformities8.8Deviation management8.9Changes and variations8.10Workshop: preparing for a GMP inspection
9.1FDA: NDA, BLA and ANDA9.2FDA expedited designations9.3Health Canada and the TGA9.4PMDA in Japan9.5NMPA in China9.6Reliance and collaborative procedures9.7Project Orbis and the Access Consortium9.8Registration in Latin America9.9Language and labelling requirements9.10Case study: global launch strategy
10.1Regulation (EC) 1234/2008 on variations10.2Type IA, IB and II variations10.3Renewals and the sunset clause10.4Transfers of marketing authorisation10.5Labelling management10.6Market withdrawals10.7Medicine shortages10.8Regulatory information management systems10.9IDMP and SPOR10.10Practical exercise: classifying a product's variations
11.1Advanced therapies and Regulation (EC) 1394/200711.2EMA scientific advice11.3PRIME and early access11.4AI in medicine development11.5Real-world data in decision-making11.6Health technology assessment and Regulation (EU) 2021/228211.7Digital therapeutics11.8Regulatory sandboxes11.9Sustainability and the environment11.10Case study: scientific advice plan
12.1Product selection and context12.2Analysis of the applicable framework12.3Regulatory strategy by market12.4Development and evidence plan12.5Dossier structure12.6Vigilance plan12.7Timeline and budget12.8Regulatory risks and mitigation12.9Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so the programme is compatible with full-time work.
Each module combines theory, guided reading of the original regulation and applied exercises. The working software is Veeva Vault RIM, Lorenz docuBridge, EudraVigilance, CTIS and Microsoft Project, in free, academic or evaluation versions. Work is based on real procedures: preparation of simulated dossiers in eCTD format, assessment of pharmacovigilance signals and preparation for good-practice inspections. Assessment is continuous by module, plus the final Master's Thesis.
Standards covered: Directive 2001/83/EC, Regulation (EC) 726/2004, Regulation (EU) 536/2014, Regulation (EU) 2017/745, ICH E6, ICH M4, Regulation (EC) 1234/2008, Royal Legislative Decree 1/2015.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- University degree in engineering, science or architecture, or equivalent demonstrable professional experience.
- Internet connection and a computer capable of running the programme software.
- English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with Veeva Vault RIM, Lorenz docuBridge, EudraVigilance, CTIS and Microsoft Project, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.
A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the programme software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
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