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Regulatory Affairs Management

Regulatory affairs managers in the life sciences industry combine technical, regulatory and strategic knowledge. This CAS focuses on the strategic requirements. You will develop communication and negotiation skills, as well as digital skills – particularly in the use of artificial intelligence (AI). You will also learn about the design of clinical trials and the statistics behind them. In addition, you will develop regulatory strategies that meet current requirements, such as Supply Chain 4.0, while taking green initiatives into account.

Factsheet

  • Degree/Certificate Certificate of Advanced Studies (CAS)
  • Duration Week 17 to week 40
  • Schedule Friday: 1pm to 7.30pm
  • Application deadline 23 september
    8–24 participants
  • ECTS credits 12 ECTS credits
  • Costs CHF 7500
  • Teaching language English
  • Location Biel, Aarbergstrasse 46 / Online
  • School School of Engineering and Computer Science
  • Next session Autumn 2025

Contact

CAS Regulatory Affairs Management

Structure + Content

In this CAS, you gain strategic knowledge. Knowledge, that involves communication and negotiations with stakeholders and authorities, process optimization through AI, sustainable regulatory strategies, and effective interface management.

Portrait

Knowledge of a regulatory affairs manager in the healthcare industry Enlarge image
Knowledge of a regulatory affairs manager in the healthcare industry

This programme emphasises communication (speaking and writing) as a critical skill, particularly for regulatory professionals who interact with a global audience, including manufacturers, authorities, and Notified Bodies.

To develop clinical trials, an understanding of statistical methods and data interpretation is essential. You will learn the language of statistics and what questions to ask the statistician when you need to write your documents.

The integration of artificial intelligence (AI) is transforming the regulatory landscape. This CAS explores how AI can streamline processes.

To engage effectively with Supply Chain 4.0, an understanding of technologies such as artificial intelligence (AI), the internet of things (IoT), and data analytics are essential. You will explore how these tools drive real-time visibility, automation, and faster decision-making, enhancing responsiveness, efficiency and patient safety.

This CAS addresses also the ethical und sustainability challenges in regulatory affairs, including their impact on clinical trials, product development, and environmental compliance.

The CAS comprises five thematically independent modules, that can also be taken as separate SAS (Short Advanced Studies). Each module begins with topic-specific face-to-face teaching and ends with a project assignment. The project assignments of each module are divided into medical devices and pharmaceuticals, allowing you to focus on your specific field of interest.

  • You work in regulatory affairs and don’t want to miss out on the latest developments in the field, such as artificial intelligence (AI).
  • You work in development, manufacturing, quality management or regulatory affairs and would like to improve your skills in
    • communicating and medical/technical writing in regulatory affairs.
    • the principles of clinical trial design and understanding and evaluating statistics in medicine.
    • the challenges of ethics that are faced by regulatory affairs professionals.
    • understanding the concepts of digital supply chain management.
  • You work in the medical device or pharmaceutical industry and would like to learn more about topics like “Green Hospital” and sustainability.

Ideally you have a degree in medicine, pharmacy, chemistry or life sciences, engineering, law, materials science, business studies or a related field, together with a basic understanding of regulatory affairs in the medical device or pharmaceutical industry.

Communication / Medical writing in Regulatory Affairs

  • Establishing a communication strategy
  • Practical communication skills
  • Technical writing (medical devices)
  • Medical writing (pharmaceuticals)
  • Introduction to project assignments
  • Individual self-study 
  • Working on project assignments 

Understanding and evaluating statistical statements in medicine

  • Regulatory aspects
  • Research design
  • Statistical methodologies
  • Introduction to project assignments
  • Individual self-study 
  • Working on project assignments

Application of artificial intelligence (AI) in everyday working life of a regulatory affairs professional

  • Ethical challenges of using AI in healthcare
  • AI in medical device industries
  • AI in pharmaceutical industries 
  • Introduction to project assignments 
  • Individual self-study 
  • Working on project assignments 

Digital Supply Chain Management

  • Fundamentals of Supply Chain Management
  • Supply Chain 4.0
  • Introduction to project assignments
  • Individual self-study 
  • Working on project assignments

Ethics and sustainability 

  • Ethical challenges in regulatory affairs 
  • Sustainability in the lifecycle management (medical devices) 
  • Sustainability in the lifecycle management (pharmaceuticals) 
  • Individual self-study 
  • Working on project assignments
Skills Profile CAS Regulatory Affairs Mastery

Levels of competence

  1. Knowledge of terms, definitions, and regulations; factual knowledge.
  2. Understanding the context, ability to explain complex matters.
  3. Applying knowledge in simple situations.
  4. Analysing one’s own solution method.
  5. Synthesis of new solutions and application in complex situations.
  6. Assessing applicability for specific problems and situations, evaluating of methods and of alternatives, connections with other fields of expertise.

A module may include a variety of teaching methods such as lectures, seminars, case studies, practical labs, assignments, etc.

For the 12 ECTS credits to be recognised, successful completion of the competency assessment is required (exercises, project work and exam).

As a rule, a university degree and practical experience are required for admission. 
People with a high vocational training can apply, provided they have suitable professional experience and prior scientific and methodological knowledge. 

Ideally you have a degree in medicine, pharmacy, chemistry or life sciences, engineering, law, materials science, business studies or a related field, together with a basic understanding of regulatory affairs in the medical device or pharmaceutical industry.

Legal foundations - Bern University of Applied Sciences

Degree + Titel

Certificate of Advanced Studies (CAS) in «Regulatory Affairs Management»

Infoevent and Course guidance

Do you have questions about the continuing education programme? The head of degree program, CAS supervisor and lecturers will answer your questions at our information events.

Contact

Fabienne Weiss

  • Wissenschaftliche Mitarbeiterin
  • +41 31 848 32 15
  • Show e-mail

Miriam Patwa

  • Studienkoordinatorin Weiterbildung
  • +41 31 848 58 68
  • Show e-mail

Study Guidance for Continuing Education

Location

The CAS Regulatory Affairs Management is taught partly on site and partly remote. The study location for on-site teaching is at Aarbergstrasse 46 in the Switzerland Innovation Park Biel/Bienne (SIPBB).

Switzerland Innovation Park Biel/Bienne (SIPBB)

A location with many advantages

  • Classrooms within two minutes walking distance from Biel/Bienne railway station
  • Ideal train connections from Bern’s main railway station (every 15 minutes) and from Bern Wankdorf (every 30 minutes)
  • State-of-the-art infrastructure in the new SIPBB building
  • Various catering options in the immediate vicinity
  • Innovation and networking events

And that’s not all! Biel/Bienne is…

  • an innovation hotspot,
  • a university city,
  • an industrial and service city with numerous major players in the watchmaking, mechanical engineering, precision engineering and medical technology industries and major representatives of the communications and telecommunications sectors,
  • bordered by Lake Biel and its wide range of sports and leisure facilities,
  • a city that embodies bilingualism,
  • a town with a vibrant cultural life.

Biel Aarbergstrasse 46 (Switzerland Innovation Park Biel/Bienne)

Biel, Aarbergstrasse 46

Bern University of Applied Sciences

Engineering and Computer Science
Switzerland Innovation Park Biel/Bienne
Aarbergstrasse 46
CH 2503 Biel

Bern University of Applied Sciences

Engineering and Computer Science
Switzerland Innovation Park Biel/Bienne
Aarbergstrasse 46
CH 2503 Biel