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Regulatory Affairs Management

Regulatory affairs managers in the life sciences industry need strategic as well as technical and regulatory knowledge. The CAS in Regulatory Affairs Management focuses on the strategic requirements. In the first part, you will develop communication and negotiation skills, as well as digital skills, particularly in the area of artificial intelligence. The second part of the programme focuses on clinical trial design and the statistics behind it, as well as the development of regulatory strategies that not only meet current requirements but also incorporate green initiatives. Knowledge of marketing analytics and marketing regulations completes the programme.

  • This programme is designed for professionals in development, manufacturing, quality management, or regulatory affairs in the medical device and pharmaceutical industries who wish to deepen their knowledge in the following areas:
    • Communicating and medical/technical writing in regulatory affairs, also in a global context.
    • The design of clinical trials and in the understanding of statistical statements in medicine, so that the language of statistics is no longer an obstacle when writing documents.
    • The challenges of ethics that are faced by regulatory affairs professionals.
    • The analysis and regulation of the marketing of pharmaceuticals and medical devices.
  • The CAS is aimed for those who don’t want to miss out on the latest developments in the field, such as artificial intelligence (AI).
  • This CAS is aimed at professionals in the medical device or pharmaceutical industry who are interested in topics such as 'Green Hospital' and sustainability along the product life cycle and who wish to deepen their knowledge in this forward-looking field.
Regulatory Affairs Mastery

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.

Setting

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, enhance data analysis, and improve decision making. 

Ethics underpins laws and regulations. This programme addresses the ethical challenges faced by regulatory affairs professionals and the importance of ethical practices in clinical trials, product development and regulatory compliance. Linked to ethics is sustainability: You will also learn about environmental management, recycling, and waste disposal, and best practices for sustainability and environmental compliance.

The programme ends with knowledge of marketing analysis and regulations.

  • 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.
    • the analysis and regulation of the marketing of pharmaceuticals and medical devices.
  • 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 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 science, engineering, law, materials science, business studies or a related field, along with a fundamental understanding of regulatory affairs in the medical technology or pharmaceutical industry.

Communication / Medical writing in Regulatory Affairs

  • Developing a communication strategy
  • Effective communication techniques
  • Communication with internal and external stakeholders
  • Medical and technical writing for regulatory affairs professionals
  • Technical writing: Medical devices
  • Medical writing: Pharmaceuticals

Understanding and evaluating statistical statements in medicine

  • Clinical study design
  • Statistical methodologies

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

  • Challenges of using AI in the healthcare industry
  • AI for regulatory affairs 

Ethics and sustainability in the development, product and disposal of pharmaceuticals and medical devices

Marketing analysis and regulation
 

Semester project (Living Case)

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 recognized, successful completion of the competency assessment is required (exams, semester work).

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).

Classes are held at Aarbergstrasse 46 in the new building of the Switzerland Innovation Park Biel/Bienne (SIPBB), which is withing easy reach of Biel/Bienne railway station.

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