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Regulatory Affairs Manager (m/f/d)
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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. Until market approval is granted (and beyond), a Regulatory Affairs Manager accompanies the new product. From development and successful market launch to all other sales tasks relating to the product. They oversee the often complicated approval procedures in the pharmaceutical and cosmetics industry and complete them as quickly as possible.
The Regulatory Affairs (RA) department 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 a 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 certain, 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 in Austria:
How much does a Regulatory Affairs Manager earn?
On average, Regulatory Affairs Managers in Austria earn €55,000 to €60,000 per year.
A specialist in a leading position in the field of regulatory affairs can earn very well in Austrian or international companies, depending on their experience, qualifications and level of responsibility.
Junior Regulatory Affairs Manager salary in Austria- your starting salary in Reg Affairs
A Junior Regulatory Affairs Manager in Austria earns a starting salary of around €40,000 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.
Senior Regulatory Affairs Manager salary in Austria
Regulatory Affairs Manager Tasks:
ACCOMPANYING CHEMICAL AND PHARMACEUTICAL INNOVATIONS
The tasks of Regulatory Affairs Managers 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.
Regulatory affairs managers play 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, they have to create comprehensive documentation about the product, which includes the product information on the packaging and package insert and 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. Regulatory affairs managers are also the point of contact for authorities and the press in crisis situations, for example in the event of unforeseen side effects.
- 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
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 Manager: lateral entry
For those who already work in a related field, such as quality assurance in clinical research or product development, a lateral entry into regulatory affairs can be an attractive option. In this case, targeted further training in regulatory affairs helps to acquire and expand 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. Therefore, it is rather difficult for a Regulatory Affairs Manager to make a lateral entry without a relevant academic background.
Regulatory Affairs training
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 up to date with 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:
- 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
- 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
- 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 legal regulations within the company and ensuring 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: Regulatory Affairs Assistants provide regulatory affairs support to assist with the regulatory process (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: Regulatory Affairs Specialists are 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 growing regulatory requirements worldwide, such as the MDR. This opens up excellent career opportunities and career security in the field of regulatory affairs.
Without regulatory affairs managers, products in the chemical, pharmaceutical and cosmetics industries would not reach the market. Regulatory Affairs Managers are therefore highly sought-after specialists, especially in the life sciences.
Top Vacancies: REGULARTORY 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 approval. The RA managers are responsible for ensuring rapid approval.
On average, the salary of a Regulatory Affairs Manager in Austria is between €55,000 and €60,000 per year.
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.
To become a Regulatory Affairs Manager, you need to have a degree in a natural science - for example in biology, chemistry or pharmacy. You also need knowledge of medical law and strong communication skills.
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