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Regulatory Affairs Manager (m/f/d)
In the fast-paced and highly regulated environment of the pharmaceutical, medical device and related industries, regulatory affairs managers play a crucial role. They are the bridge between companies and regulatory authorities and ensure that chemical, cosmetic and pharmaceutical products and processes comply with the applicable legal requirements.
Here you can find out exactly what your tasks are, what salary you can expect and what knowledge and skills you should have for this job.
Here you can find out exactly what your tasks are, what salary you can expect and what knowledge and skills you should have for this job.
Are you looking for a job as a Regulatory Affairs Manager (m/f/d)?
Do you come from a scientific/medical background and also have industry experience in regulatory affairs? Do you support products from the chemical, pharmaceutical and cosmetics industries from development to market entry? Find your new challenge with us now.
Are you looking for an experienced Regulatory Affairs Manager (m/f/d)?
Are you looking for qualified Regulatory Affairs Managers? These professionals play a major role in the life sciences as they coordinate an important part of development, production and licensing.
Bring the support of specialists into your company. We can help you!
Bring the support of specialists into your company. We can help you!
Are you looking for Regulatory Affairs Manager (m/f/d) projects?
Have you already supported projects in Regulatory Affairs and are looking for new challenges as a freelancer? Then take a look at our project exchange and find companies that need project support in regulatory affairs.
What is a Regulatory Affairs Manager? Definition and overview
For a cosmetic product or medicine to be launched on the market, it must meet strict requirements. The Regulatory Affairs Manager supports the new product until market approval is granted (and beyond). From development to successful market entry and all other sales tasks relating to the product. They manage and supervise the often complicated approval procedures in the pharmaceutical and cosmetics industry and complete them as quickly as possible.
Regulatory Affairs (RA) is involved in product development from the very beginning. This includes all phases of clinical studies, the application for approval and the production process, which only takes place after approval has been granted. They coordinate the various departments involved in the project. They are the important interface between the company and the regulatory authorities.
Due to the strict approval guidelines in these areas, the profession of RA manager is mainly found in the cosmetics, pharmaceutical and chemical industries, where it is unavoidable.
Their main aim is to bring the respective product to market quickly and cost-effectively and to retain approval for as long as possible. However, this is not always the case, as the path from development to approval can take up to ten years and require many revisions.
Since May 2021, the approval of new medical products has become even more complex due to the Medical Device Regulation (MDR). As a result, RA managers play an even more important role in the approval of medicines in Europe and are therefore in greater demand.
Regulatory Affairs (RA) is involved in product development from the very beginning. This includes all phases of clinical studies, the application for approval and the production process, which only takes place after approval has been granted. They coordinate the various departments involved in the project. They are the important interface between the company and the regulatory authorities.
Due to the strict approval guidelines in these areas, the profession of RA manager is mainly found in the cosmetics, pharmaceutical and chemical industries, where it is unavoidable.
Their main aim is to bring the respective product to market quickly and cost-effectively and to retain approval for as long as possible. However, this is not always the case, as the path from development to approval can take up to ten years and require many revisions.
Since May 2021, the approval of new medical products has become even more complex due to the Medical Device Regulation (MDR). As a result, RA managers play an even more important role in the approval of medicines in Europe and are therefore in greater demand.
Regulatory Affairs Manager salary: How much does a Reg Affairs Manager earn?
The minimum salary is €45,000 gross per year and can easily rise to almost double that. On average, Regulatory Affairs Managers in Germany earn €53,000 per year.
A specialist in a leading position in Regulatory Affairs can earn very well in German or international companies, depending on their experience, qualifications and level of responsibility.
A specialist in a leading position in Regulatory Affairs can earn very well in German or international companies, depending on their experience, qualifications and level of responsibility.
Junior Regulatory Affairs Manager salary - your starting salary in Reg Affairs
A Junior Regulatory Affairs Manager in Germany earns an average starting salary of around €45,000 to €50,000 per year.
As with most jobs, the salary depends on experience, location and the size of the company. Therefore, salaries in this field can vary greatly for both Senior and Junior Regulatory Affairs Managers.
As with most jobs, the salary depends on experience, location and the size of the company. Therefore, salaries in this field can vary greatly for both Senior and Junior Regulatory Affairs Managers.
Senior Regulatory Affairs Manager Salary
With increasing experience and responsibility, the salary of a Senior Regulatory Affairs Manager can rise to between €70,000 and €100,000 or more. Management responsibility contributes most to a higher salary for Senior Managers.
Regulatory Affairs Manager salary in Switzerland: How much does a Swiss Regulatory Affairs Manager earn?
On average, Regulatory Affairs Managers in Switzerland earn a salary of between CHF 90,000 and CHF 135,000 per year. With these salaries, however, it should be noted that the cost of living in Switzerland is also many times higher.
Regulatory Affairs Manager Tasks: As a specialist in chemical and pharmaceutical innovation, accompany
The tasks of a Regulatory Affairs Manager include the strategic planning of approval processes, communication with authorities and monitoring international legislation. They work closely with other departments such as Research and Development, Production and Marketing.
The Regulatory Affairs Manager plays an important role in development, production and licensing to ensure that the finished products meet the requirements of the regulatory authorities as perfectly as possible. At the same time, regulatory affairs managers have to create comprehensive documentation about the product, including the product information on the packaging and package insert, which forms the basis for market approval by the authorities.
The experts are also an important part of the marketing team, as they ensure that new cosmetics, medicines and chemical products are advertised correctly. In crisis situations, such as unforeseen side effects, the Regulatory Affairs Managers are also the contact persons for authorities and the press.
The Regulatory Affairs Manager plays an important role in development, production and licensing to ensure that the finished products meet the requirements of the regulatory authorities as perfectly as possible. At the same time, regulatory affairs managers have to create comprehensive documentation about the product, including the product information on the packaging and package insert, which forms the basis for market approval by the authorities.
The experts are also an important part of the marketing team, as they ensure that new cosmetics, medicines and chemical products are advertised correctly. In crisis situations, such as unforeseen side effects, the Regulatory Affairs Managers are also the contact persons for authorities and the press.
The most important tasks of a Regulatory Affairs Manager:
- Advice and involvement in design and development
- Preparation and submission of approval documents
- Coordination of new products with regulatory requirements
- Comprehensive documentation of the entire product development process
- Advising the marketing department and reviewing all texts and content
- Communication with regulatory authorities
- Crisis communication in the event of negative effects
- Protection of information and data privacy
How do you become a Regulatory Affairs Manager? Studies, training and lateral entry
The career path to Regulatory Affairs Manager offers various opportunities for entry and advancement. In general, this position requires solid knowledge of the life sciences, supplemented by specific knowledge and skills in the area of regulatory requirements. This is usually achieved through a Bachelor's and/or Master's degree, which is also a prerequisite for most employers.
Regulatory Affairs studies: The academic path via life sciences
A degree in the life sciences, such as biology, chemistry or pharmacy, is often the first step on the path to a career as a Regulatory Affairs Manager. A Master's degree or doctorate can further improve career opportunities. In addition, there are special degree and certificate programs in regulatory affairs that offer a deeper insight into the regulatory requirements and processes in the pharmaceutical and medical device industry.
You can find a course in regulatory affairs here, for example:
- Regulatory Affairs (Master) at the TU Lübeck
- Drug Regulatory Affairs (Master) at the University of Bonn
- Medical Technology – Regulatory Affairs (Master's degree, part-time) at Furtwangen University
Regulatory Affairs Manager lateral entry
For those already working in a related field, such as quality assurance, clinical research or product development, a career change into regulatory affairs can be an attractive option. In this case, targeted further training in regulatory affairs can help to acquire the necessary knowledge and skills.
Specific training courses that help with direct lateral entry are rare. A degree is always a prerequisite for a career as a Regulatory Affairs Manager. It is therefore rather difficult for a Reg Affairs Manager to make a lateral entry without an academic background.
Specific training courses that help with direct lateral entry are rare. A degree is always a prerequisite for a career as a Regulatory Affairs Manager. It is therefore rather difficult for a Reg Affairs Manager to make a lateral entry without an academic background.
Regulatory Affairs training
Regulatory requirements and processes in the pharmaceutical and medical device industry are constantly changing. Continuous training is therefore essential for regulatory affairs managers. This can be done by attending specialist conferences, participating in webinars or completing training courses. There are also various certification programs that can help to deepen and update competence and expertise in this area.
You can find helpful further training courses at the TÜV Rheinland Academy or the FORUM Institute for Management.
You can find helpful further training courses at the TÜV Rheinland Academy or the FORUM Institute for Management.
Regulatory Affairs Manager Skills: The required hard and soft skills
A Regulatory Affairs Manager must have a degree in medicine, pharmacy, biochemistry or a comparable natural science subject. Experience in the relevant industry is just as important as knowledge of medical law and English language skills. As the legal regulations and requirements in the profession are constantly changing and developing, regulatory affairs specialists must undergo ongoing training in order to keep abreast of current events.
Leadership skills, negotiating and assertiveness skills and resilience are required for communication with internal company teams, authorities and the media, but also for possible crisis management.
Specific hard skills of Regulatory Affairs Managers are:
Leadership skills, negotiating and assertiveness skills and resilience are required for communication with internal company teams, authorities and the media, but also for possible crisis management.
Specific hard skills of Regulatory Affairs Managers are:
- Completed studies in natural sciences and medicine
- Industry experience and further training in regulatory affairs
- Knowledge of medical law (relevant laws, directives and regulations)
- Good foreign language skills
The soft skills of RA managers include:
- Ability to work in a team and under pressure
- Leadership and communication skills
- Ability to make complex issues understandable
- Negotiating skills
- Reliability
The different roles in Regulatory Affairs: Manager, Assistant and Specialist
There are various roles in the area of Regulatory Affairs. In addition to the Regulatory Affairs Manager, there are also RA Assistants and RA Specialists. These differ in the details. However, it is important to note that the exact tasks and responsibilities can vary depending on the industry and company.
- Regulatory Affairs Manager: A Regulatory Affairs Manager is an important link between a pharmaceutical or cosmetics company and the regulatory authorities. They are responsible for monitoring the legal regulations within the company and ensure that the new product can clear all legal hurdles. You prepare all the steps for successful approval and accompany the entire product approval process from development to sale. You work together with testing organizations and the relevant authorities and use scientific studies and well-founded arguments to convince approval bodies of the effectiveness of the products.
- Regulatory Affairs Assistant: A Regulatory Affairs Assistant provides regulatory affairs support to assist with regulatory affairs (new registrations, renewals and change registrations). They ensure compliance with applicable medical device regulations per jurisdiction, guidelines and standards and assist in the creation and maintenance of regulatory files.
- Regulatory Affairs Specialist: A Regulatory Affairs Specialist is responsible for creating, reviewing and updating regulatory documents for medical devices, taking into account national and international regulations. They work closely with the relevant authorities to ensure the smooth approval and conformity of products. They assess the regulatory impact of product changes and initiate appropriate measures.
Regulatory Affairs Manager opportunities on the job market
The demand for qualified regulatory affairs managers is constantly increasing due to regulatory requirements worldwide, such as the MDR. This opens up excellent career opportunities and career security in the field of regulatory affairs.
The Hays Skilled Workers Index 2023 (FKI), which analyzes the job advertisements of all major job portals in Germany every year, also shows that the demand for regulatory affairs managers is rising again after a drop at the end of 2022. This is a positive development compared to other professions in the life sciences (e.g. chemists), where demand continues to fall.
Without regulatory affairs managers, products in the chemical, pharmaceutical and cosmetics industries would not reach the market. Regulatory Affairs Managers are therefore sought-after specialists, especially in the life sciences. Open positions are filled in Berlin, Hamburg, Frankfurt and Munich in particular.
Top Vacancies: regulatory affairs manager Jobs (m/f/d)
FAQ
A Regulatory Affairs Manager is responsible for the approval of chemical, medical or cosmetic products. These products are subject to numerous regulations and are strictly checked before they are approved. RA managers are therefore responsible for the entire life cycle of these products - even after approval.
A Regulatory Affairs Manager is responsible for the approval of chemical, medical or cosmetic products. These products are subject to numerous regulations and are strictly checked before they are approved. RA managers are therefore responsible for the entire life cycle of these products - even after approval.
On average, the salary of a Regulatory Affairs Manager in Germany is around €53,000 gross per year. You can expect a starting salary of around €49,000.
A Regulatory Affairs Assistant supports their team in preparing for the approval of a medical, chemical or cosmetic product. This involves taking all the regulatory measures required to obtain approval quickly.
To become a Regulatory Affairs Manager, you need to have a degree in a natural science - for example, biology, chemistry or pharmacy. You also need knowledge of medical law and good communication skills.