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.

For applicants

REGULATORY AFFAIRS MANAGER

  • For applicants
  • For companies

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!

Find a qualified regulatory affairs manager

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

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

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

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

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

Relevant contract types

Top job offers for regulatory affairs manager

Reference number: 814833/1

Medical Affairs Manager (m/f/d)

Permanent employment with our customer
Rapperswil-Jona
  • Foster Scientific Relationships: Establish and maintain high-level scientific relationships with medical opinion leaders in multiple European countries
  • Provide Medical Information: Ensure high-quality and balanced medical, pharmaceutical, and scientific support for the Grafalon business area
  • Organize Events and Meetings: Conduct scientific and educational meetings in accordance with regulatory and legal frameworks
  • Develop External Relationships: Identify and build solid professional relationships with national and international key opinion leaders
  • Support Research: Assist in the local and global implementation of Neovii-sponsored studies and projects, and manage clinical trials and scientific research projects
  • Medical Planning: Contribute to the development of the medical plan and support global and local strategies and tactics
  • Maintain Standards: Adhere to relevant global and local codes of practice and behave ethically
  • Frequent travel (approximately 50% of the time)
Online since: Mon Mar 31 11:08:58 CEST 2025
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Reference number: 797097/1

(Junior) Regulatory Affairs Manager (m/w/d)

Festanstellung durch unseren Kunden
Baden-Württemberg
  • Beschaffung, Analyse und anwendungsorientierte Interpretation von internationalen Gesetzen, Verordnungen, Normen und Standards bezüglich IVD Produkte und Umsetzung dieser in interne Handlungsanweisungen
  • Unterstützung bei der Umsetzung von Regulatory Affairs Anforderungen hinsichtlich in vitro diagnostische Produkte 
  • Eigenständige Beratung und Unterstützung hinsichtlich der Erzielung und Aufrechterhaltung gesetzlicher Konformität
  • Praxisbezogene Unterstützung bei der Implementierung von internationalen behördlichen Anforderungen (z.B. Produkt- und Hersteller Registrierung, Lizensierung)
  • Selbstständige Erstellung von deutsch- und englischsprachigen Anforderungsdokumenten für Regulatory Affairs mit Fokus auf IVD
  • Überwachung bestehender Registrierungen und ggf. Re-Registrierungen
  • Mitarbeit bei der Priorisierung der Länderregistrierung in Bezug auf IVD-Produkte
  • Mitwirkung bei Zulassungsverfahren, hauptsächlich für die USA (FDA)
  • Enge Zusammenarbeit mit diversen unterschiedlichen Stakeholdern
  • Schnelle Einarbeitung und Übernahme von Verantwortung
Online since: Mon Apr 07 14:39:56 CEST 2025
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Reference number: 811416/1

Regulatory Affairs Manager (m/w/d)

Festanstellung durch unseren Kunden
Tübingen
  • Sicherstellung der Einhaltung aller relevanten nationalen und internationalen Chemikalienvorschriften (z.B. EU-REACH)
  • Kommunikation mit Behörden und externen Partnern bezüglich regulatorischer Anforderungen
  • Überwachung und Implementierung neuer gesetzlicher Bestimmungen und Richtlinien
  • Unterstützung bei der Registrierung und Zulassung neuer Produkte
  • Beurteilung bestehender Produkte in Bezug auf geltende gesetzliche Regelungen im Zusammenhang mit dem Chemikalien- und Umweltrecht sowie nachgelagerten Regelungen in Europa (z.B. PFAS)
Online since: Mon Apr 07 14:40:40 CEST 2025
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Reference number: 808249/1

Regulatory Affairs Manager / QM Medizintechnik (m/w/d)

Festanstellung durch unseren Kunden
Baden-Württemberg
  • Verantwortung, Sicherstellung und kontinuierliche Verbesserung des Qualitätsmanagementsystems gemäß ISO 13485 und MDSAP
  • Planung, Durchführung und Überwachung von Validierungs- und Verifizierungstätigkeiten
  • Erstellung und Pflege technischer Dokumentationen gemäß MDR
  • Vorbereitung und Durchführung von internen und externen Audits sowie Unterstützung bei Zertifizierungsprozessen
  • Bearbeitung von Reklamationen
  • Dokumentation und Analyse von Qualitätskennzahlen zur kontinuierlichen Verbesserung von Produkten und Prozessen
  • Ansprechpartner für interne und externe regulatorische Fragen und Projekte
  • Zusammenstellung von Registrierungsunterlagen für internationale Zulassungen
  • Kontaktperson für Zulassungsbehörden 
  • Management internationaler Registrierungsprojekte
Online since: Mon Apr 07 14:39:45 CEST 2025
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Reference number: 809367/1

Product Compliance Manager (m/w/d)

Festanstellung durch unseren Kunden
Landkreis Böblingen
  • Eigenständige Recherche und Bewertung von regulatorischen Anforderungen im Bereich Produktkonformität (z.B. RoHS, REACH, CE)
  • Unterstützung der relevanten Fachabteilungen bei der Implementierung dieser regulatorischen Vorgaben
  • Verantwortung für das Management von rechtsverbindlichen Konformitätserklärungen in Bezug auf Produkte und Märkte (Regulatory Affairs)
  • Nterstützung der Fachabteilungen bei der Analyse, Optimierung und Dokumentation interner Prozessabläufe und Schnittstellen
  • Leitung von abteilungsübergreifenden Projekten
Online since: Mon Apr 07 14:32:04 CEST 2025
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