Job profile
Regulatory affairs manager (m/f/d)

Regulatory affairs managers: preparing new products for their market launch

Cosmetics and drugs must meet strict requirements to obtain approval for market launch. In this context, regulatory affairs managers are responsible for the entire process – from the product development phase until the final introduction. They manage and supervise the often complicated approval procedures in the pharmaceutical and cosmetics industries. Regulatory affairs managers are involved in product development from the very beginning. This includes all phases of clinical studies, the application for approval up to the production process, which only takes place after the approval has been granted. They coordinate the various departments involved in the project. They act as interfaces between companies and regulatory authorities.

Which opportunities do regulatory affairs managers have on the labour market?

In the chemical, pharmaceutical and cosmetics industry, regulatory affairs managers are essential to bring new products into markets. Thus, regulatory affairs managers are experts highly in demand, especially in Life Sciences and in cities like Berlin, Hamburg, Frankfurt or Munich.

REGULATORY AFFAIRS MANAGER

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Are you looking for a job as a regulatory affairs manager'?

Do you have a background in the scientific-medical field and also have industry experience in the area of regulatory affairs? Support products from the chemical, pharmaceutical and cosmetics industries from development to market entry and coordinate the various departments involved in the project. Contact us and we will take your next career steps together.

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Are you looking for an experienced regulatory affairs manager?

Are you looking for a qualified regulatory affairs manager? These specialists play a major role in the life sciences field, as they coordinate an important part of the development, production and licensing of new products. Get support of experienced professionals for your company. We can help you with that!

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What are the tasks and responsibilities of regulatory affairs managers?

By making an important contribution to the development, production and licensing of products and ensuring their compliance with the requirements of regulatory authorities, regulatory affairs managers promote chemical and pharmaceutical innovations. Furthermore, they prepare comprehensive documentations of products, including product information for packaging and package inserts, required for the approval for market entry by the authorities.

Regulatory affairs managers are important in marketing as well since they ensure the appropriate advertising of cosmetics, drugs and chemical products. Last but not least, they are the point of contact for authorities and the press in critical situations, e.g. in case of unforeseen adverse reactions.

The most important tasks of a Regulatory Affairs Manager:

  • Providing advice and support during the conceptual and development phase
  • Ensuring the compliance of new products with regulatory requirements
  • Preparation of comprehensive documentations of complete product development processes
  • Providing advice to the marketing department
  • Communication with regulatory authorities
  • Crisis communication in case of adverse reactions
  • Protection of information and data protection
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By making an important contribution to the development, production and licensing of products and ensuring their compliance with the requirements of regulatory authorities, regulatory affairs managers promote chemical and pharmaceutical innovations. Furthermore, they prepare comprehensive documentations of products, including product information for packaging and package inserts, required for the approval for market entry by the authorities.

Regulatory affairs managers are important in marketing as well since they ensure the appropriate advertising of cosmetics, drugs and chemical products. Last but not least, they are the point of contact for authorities and the press in critical situations, e.g. in case of unforeseen adverse reactions.

The most important tasks of a Regulatory Affairs Manager:

  • Providing advice and support during the conceptual and development phase
  • Ensuring the compliance of new products with regulatory requirements
  • Preparation of comprehensive documentations of complete product development processes
  • Providing advice to the marketing department
  • Communication with regulatory authorities
  • Crisis communication in case of adverse reactions
  • Protection of information and data protection
Minimise More info

Which hard skills and soft skills should regulatory affairs managers have?

Regulatory affairs managers must have an academic degree in medicine, pharmacy, biochemistry or a similar science. Besides, they must have relevant industry experience, knowledge of medical law and good English skills. As the legal regulations and requirements are continuously changing and evolving, regulatory affairs managers must regularly improve their knowledge to always be up-to-date.

Strong management and negotiation skills, assertiveness and the ability to work under pressure are required to communicate with internal teams, authorities and the press and to successfully handle critical situations.

Requirements for the job of Regulatory Affairs Manager:

  • An academic degree in science/medicine
  • Industry experience and knowledge of regulatory affairs
  • Expertise in medical law
  • Good foreign language skills
  • Team spirit and resilience
  • Strong management and communication skills
Minimise More info

Regulatory affairs managers must have an academic degree in medicine, pharmacy, biochemistry or a similar science. Besides, they must have relevant industry experience, knowledge of medical law and good English skills. As the legal regulations and requirements are continuously changing and evolving, regulatory affairs managers must regularly improve their knowledge to always be up-to-date.

Strong management and negotiation skills, assertiveness and the ability to work under pressure are required to communicate with internal teams, authorities and the press and to successfully handle critical situations.

Requirements for the job of Regulatory Affairs Manager:

  • An academic degree in science/medicine
  • Industry experience and knowledge of regulatory affairs
  • Expertise in medical law
  • Good foreign language skills
  • Team spirit and resilience
  • Strong management and communication skills
Minimise More info

Regulatory Affairs Manager Salary: What do specialists earn?

Depending on their experience, qualification and level of responsibility, regulatory affairs managers holding a leading position at a German or international company have a very good annual salary, earning between EUR 45,000 and almost EUR 90,000.

Fill our open Regulatory Affairs Manager jobs

As a highly qualified regulatory affairs manager, you contribute both your specialist knowledge and your broad range of qualifications and skills to your employer’s success. If you want to boost your career, Hays is the perfect point of contact. Get in touch with us and learn more about the benefits of finding a job with Hays

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