Junior Specialist Regulatory - Global Specialty Development (f/m/d) Job Details | STADA Arzneim[...]

STADA; Bad Vilbel; Hybrid; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen Junior Specialist im Bereich Regulatory Affairs. In dieser spannenden Rolle unterstützen Sie die regulatorischen Programme für globale Biosimilars und Spezialprodukte. Sie werden an der Vorbereitung und Einreichung von Marketinggenehmigungsanträgen arbeiten und sicherstellen, dass alle erforderlichen Dokumente korrekt und fristgerecht eingereicht werden. Diese Position bietet Ihnen die Möglichkeit, in einem dynamischen, internationalen Team zu arbeiten und Ihre Fähigkeiten in einem unterstützenden Umfeld weiterzuentwickeln. Wenn Sie eine Leidenschaft für die Gesundheitsbranche haben und in einem innovativen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Flexible Arbeitszeiten

Mobiles Arbeiten

Jobticket

Kindergeld

Gesundheitsfördernde Angebote

Subventionierte Cafeteria

Individuelle Entwicklungsmöglichkeiten

Kostenloses Fitnessstudio

Qualifikationen

• Abschluss in Lebenswissenschaften oder relevante pharmazeutische Ausbildung erforderlich.
• Erste Erfahrungen im Bereich Regulatory Affairs sind von Vorteil.

Aufgaben

• Unterstützung des Managements von regulatorischen Programmen für Biosimilars.
• Vorbereitung und Einreichung von Marketinggenehmigungsanträgen.

Kenntnisse

Regulatory Affairs

IT Systems

Detail-oriented

Communication Skills

Fluent in English

Knowledge of Regulatory Systems

Ausbildung

Degree in Life Sciences

Pharmaceutical/Medical Technical Training

Tools

Regulatory Software

Document Management Systems

Jobbeschreibung

Caring for People's Health as a Trusted Partner - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Junior Specialist Regulatory - Global Specialty Development (f/m/d)

Bad Vilbel | Germany (DE) | Full-time | Permanent | Portfolio & Product Development

What you can expect

• You support regulatory program management activities within global biosimilar and specialty projects.
• You contribute to the preparation and submission of Marketing Authorization Applications (MAAs).
• You create and manage administrative documents (Module 1) for global submissions.
• You provide regulatory support in the development and review of packaging material artworks.
• You manage product information texts and coordinate translations across multiple markets.
• You prepare and publish eCTD sequences and handle documents using document management systems.
• You maintain regulatory data in internal databases and support xEVMPD submissions.
• You collaborate with internal stakeholders and external partners to ensure regulatory compliance.

Whom we are looking for

• You hold a degree in life sciences or have completed relevant pharmaceutical/medical technical training.
• You have a strong affinity for IT systems and enjoy working with regulatory software and tools.
• You bring a structured, detail-oriented working style and a high level of accuracy.
• You are able to interpret complex regulatory requirements and apply them to real-world cases.
• You manage multiple tasks efficiently and set clear priorities under tight timelines.
• You communicate clearly and proactively within cross-functional and international teams.
• You are fluent in English, both written and spoken; German or any additional language is a plus.
• You ideally bring first experience in Regulatory Affairs or knowledge of regulatory systems and databases.

What we offer

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development.
• Individual development and training opportunities.
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile).
• Job ticket for the RMV region and Job Bike.
• Childcare allowance.
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge).
• Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund.
• Subsidized cafeteria.

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to [e-mail]. Part-time requests are considered on an individual basis.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.