Since 1948, DENK PHARMA GmbH & Co. KG has been operating as a family-owned business in more than 80 countries. Under our slogan “Quality for your Health – Made in Germany,” we use our products to provide all our customers with access to healing. As one of the few pharmaceutical companies worldwide, we ensure that all our customers receive exactly the same medications and dietary supplements as those available in Germany. To guarantee this, nearly 100% of our products are manufactured, quality-controlled and approved in Germany.
(Junior) Manager (m/w/d) Labeling
München
Full-time
Permanent employee
About Denk Pharma:
The Role at a Glance
As a (Junior) Labeling Manager (m/f/d), you will be responsible for creating, maintaining, and submitting product information texts for our portfolio of pharmaceuticals and dietary supplements to regulatory authorities. You will ensure that our texts comply with the requirements of national and European regulatory authorities at all times, thereby making a significant contribution to the market availability and regulatory compliance of DENK PHARMA’s products.
This is how you can make an impact:
- Regulatory Affairs
- Text Management: Create, review, and update product information texts for medicinal products in accordance with the current requirements of the BfArM, the EMA, and other relevant authorities—thereby ensuring regulatory compliance across our entire portfolio.
- Submission Planning: Develop and maintain a structured submission plan and submit revised mandatory texts as part of national and European marketing authorization and variation procedures to ensure that regulatory deadlines are reliably met.
- Regulatory Communication: Independently communicate with regulatory authorities such as the BfArM and EMA to establish a solid foundation for efficient marketing authorization and variation procedures.
- Dietary Supplement Management
- Central Management of Regulatory Dietary Supplement Issues: Serve as the single point of contact (SPOC) for regulatory issues related to dietary supplements, coordinate cross-departmental collaboration, and ensure that all relevant departments have a consistent level of information.
- Maintenance of Regulatory Documentation: Create and update product texts, dossiers, and ordering lists for dietary supplements, thereby ensuring that all relevant documents are up to date and compliant with regulatory requirements.
- Interface Management
- Internal Collaboration: Collaborate closely with Sales, Supply Chain, Quality, and Pharmacovigilance to ensure that processes along the entire approval chain run smoothly and seamlessly.
- Originator Text Comparisons: Work with the Pharmacovigilance team to conduct regular comparisons of originator and existing texts, assess the need for changes, and initiate the necessary regulatory actions.
- Project Coordination: Coordinate ongoing labeling projects with the team lead and proactively keep all stakeholders informed so that dependencies are identified early and risks are minimized.
- Process Optimization
- Documentation Standards: Develop and maintain standardized templates and process documentation to ensure that knowledge is preserved within the team over the long term and that new colleagues can quickly become productive.
- Quality Assurance: Identify weaknesses in existing labeling processes and propose targeted improvement measures that permanently reduce efficiency and error rates.
Here´s what you should bring:
- Professional Background: You hold a degree in pharmacy, natural sciences, or a comparable qualification and have professional experience in copywriting or regulatory affairs.
- Regulatory Expertise: You have already gained experience in drafting or maintaining regulatory documents and are familiar with national and European regulatory requirements.
- Linguistic Precision: A highly structured, conceptual approach to work and a high degree of accuracy when handling complex texts come naturally to you—complemented by excellent German and English skills; knowledge of Spanish is a welcome plus, and we’re happy to offer relevant language courses.
- Commitment to Responsibility: You work independently, reliably, and with a strong sense of responsibility—and you enjoy actively helping to shape and continuously improve processes.
- Communication and Team Skills: You are comfortable collaborating across departments, communicating clearly, and tailoring your messages to the audience—both internally and with external authorities and partners.
- Organizational skills: Ideally, you have experience in project management or coordinating multiple initiatives simultaneously, combined with strong time management skills and the ability to maintain structure even in a dynamic environment.
- AI Mindset: You are open to integrating AI-powered tools—such as those for text review, verifying compliance with regulatory requirements, or researching government guidelines—into your daily work, thereby helping to make labeling processes at DENK PHARMA more efficient and future-proof.
What we offer you:
- Work & Life – Flexible work hours and the option to work remotely
- Connect & Grow – Numerous company celebrations such as a trip to Oktoberfest, a summer party, Carnival, and a Christmas party, an annual team event, and regular after-work events on our rooftop terrace
- Share & Create – Open communication and feedback, e.g., through monthly pulse surveys as well as regular feedback and development meetings with your manager
- Level Up – Focus on and further develop your strengths, plus needs-based internal and external workshops for your personal and professional growth
- Access to healing – Health and fitness partnership with the EGYM Wellpass, free dietary supplements and snacks (fruit, nuts, and ice cream)
- Buddy Program – A point of contact for questions of all kinds and support with networking and “Get Together Lunch” events
- Plus – a shopping card, exclusive discounts through Corporate Benefits, a performance-based bonus, a company pension plan, and much more.
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.