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Junior Manager Regulatory Affairs (m/w/d)

München
Full-time
Permanent employee

About Denk Pharma:

Seit 1948 ist die DENK PHARMA GmbH & Co. KG als Familienunternehmen in mehr als 80 Ländern tätig. Unter unserem Slogan „Quality for your Health – Made in Germany" schaffen wir für alle Kunden mit unseren Produkten Zugang zur Heilung. Als eines der wenigen Pharmaunternehmen weltweit erhalten alle unsere Kunden genau die gleichen Arznei- und Nahrungsergänzungsmittel, wie sie in Deutschland erhältlich sind. Um dies sicherzustellen, werden unsere Produkte nahezu zu 100 % in Deutschland hergestellt, in Deutschland auf ihre Qualität kontrolliert und in Deutschland zugelassen.

The Role at a Glance

As Junior Manager Regulatory Affairs (m/w/d), you support the registration processes for our products across international markets and gradually grow into strategic responsibility. Through efficient dossier management and the cultivation of strong partner relationships, you contribute directly to the sustainable growth of DENK PHARMA in dynamic and fast-evolving regions.

This is how you can make an impact:

  • Regulatory Affairs
    • Dossier Preparation: Support the revision of pharmaceutical-technical dossiers in EU-CTD and country-specific formats, ensuring the regulatory requirements of our target markets are reliably met.
    • Submission Planning: Accompany the timely re-submission and maintenance of registrations through First Submissions and Renewals, so that continuous market availability of our products is guaranteed.
    • Certificate Management: Systematically track the receipt of registration certificates and, together with the team, initiate the necessary follow-up actions — keeping our submission schedule on track at all times.

  • Partner Management
    • Network Development: Nurture existing relationships with local partners and authorities while gradually building your own resilient network — laying the foundation for long-term successful market presence.
    • Partner Communication: Support communication with local registration partners, evaluate their performance together with the team, and contribute to optimisation measures, thereby continuously strengthening collaboration.

  • Market Development
    • Market Entry: Research and assess the regulatory requirements for the introduction of new products into our markets and, under guidance, implement new registration strategies — creating the basis for further growth.
    • Cost Efficiency: Contribute to ensuring cost-effectiveness through optimised registration strategies and smooth material substitution processes during product changes, so that quality and economic viability go hand in hand.

  • Process Optimisation
    • Documentation: Support the creation and maintenance of working instructions, process documentation, and country-specific checklists, ensuring consistently high quality standards across the entire team.
    • Structural Development: Actively engage in the further development of internal workflows and, together with colleagues, develop pragmatic improvements — making processes leaner and more transparent.

Here´s what you should bring:

  • Professional Background: You hold a degree in Pharmacy, Natural Sciences, or a comparable field and bring initial practical experience — for example through internships, working student roles, or a first job — ideally in Regulatory Affairs or a highly regulated environment.
  • Regulatory Experience: Ideally, you have already gained first insights into registration, variation, or dossier projects and are familiar with authority or external partner workflows from real-world practice.
  • Analytical and Structural Strength: Working carefully comes naturally to you — you grasp complex pharmaceutical documentation quickly and can derive clear next steps from it, with a structured mindset as your baseline.
  • International Communication: You navigate confidently in both German and English; knowledge of French or Spanish is a genuine plus and will ease your exchange with international partners.
  • Ownership and Proactivity: A strong drive to take on growing responsibility for your own markets or projects defines your working style — you push topics forward on your own initiative and actively seek solutions before problems arise.
  • Process Thinking: You take genuine pleasure in understanding workflows, questioning them critically, and improving them pragmatically together with the team, always keeping the bigger picture in mind.
  • KI-Mindset: You enjoy exploring new digital tools and can readily envision integrating AI-powered solutions — such as for dossier research, regulatory text analysis, or automated translation processes — into your daily work, thereby advancing quality and efficiency in registration management.

What we offer you:

  • Work & Life - Flexible Arbeitszeiten und Möglichkeit zum mobilen Arbeiten
  • Connect & Grow – Zahlreiche Firmenfeiern wie Wiesnbesuch, Sommerfest, Fasching und Weihnachtsfeier, jährliches Teamevent und regelmäßige After-Work-Events auf unserer Dachterrasse
  • Share & Create – offener Austausch und Feedback z.B. durch monatliche Pulsumfragen um Stimmungsbild Aller einzuholen und Veränderungen abzuleiten, regelmäßige Feedback- und Entwicklungsgespräche mit deiner Führungskraft
  • Level up - Fokus & Weiterentwicklung Deiner Stärken und wie du diese für dich und deine Arbeit nutzen kannst sowie bedarfsbezogene interne und externe Workshops für dein persönliches und fachliches Wachstum
  • Access to healing - Gesundheits- und Fitnesskooperation mit den EGYM- Wellpass – mit verschiedenen Sportangeboten (z.B. Fitness- und Yogastudios, Bäder, Massagen) deutschlandweit sowie kostenlose Nahrungsergänzungsmittel und Snacks (Obst, Nüsse & Eis)
  • Buddy Programm - Anlaufstelle für Fragen aller Art und Unterstützung beim Vernetzen und „Get Together Lunch"
  • Außerdem - 150 € Shoppingkarte, exklusive Rabatte über Corporate Benefits, einen performancebasierten Bonus, betriebliche Altersvorsorge, uvm.

About us

At Denk Pharma and Denk Ingredients, we jointly pursue the corporate purpose "ACCESS TO HEALING". Therefore, we align our actions according to the two closely related guiding principles: "Quality for your health - made in Germany" and "Access to health ingredients", which bring us closer to this goal. This dynamic interaction of both guiding principles unites two teams in the Denk Family. Each member of the Denk Family brings us one step closer to our goal - to provide access to healing.