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Regulatory affairs manager (m/f/d)

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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 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.

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.

  • 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

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.

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

What is the average salary of regulatory affairs managers?

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.

Finding your dream job as a regulatory affairs manager – with Hays

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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