Teamlead Regulatory Affairs EU/Germany (m/f/d)

Be part of the DENK Family and experience the diversity of our highly motivated team.

Our Core Values, ''WINNING MINDSET'' - ''GET STUFF DONE' - ''HIGH FIVE' - ''WALK THE TALK'' and ''GO BEYOND'', form the basis for our cooperation. You help us to set priorities and align our daily actions to live the determination of companies. Our international team, our values & Benefits offer you an inspiring working environment.

Come to us, grab on and we'll create great together!

DENK PHARMA GmbH & Co. KG has been active as a family business in more than 80 countries since 1948. Under our slogan “Quality for your Health – Made in Germany” we provide access to healing for all customers with our products. As one of the few pharmaceutical companies worldwide, all our customers receive exactly the same drug and dietary supplements as You are available in Germany. To ensure this, our products are manufactured almost 100% in Germany, controlled in Germany for their quality and approved in Germany.

The role at a glance As Teamleader (m/w/d) Regulatory Affairs EU/Germany, you take over the professional and disciplinary leadership of a dedicated team that focuses on the German and European market and control complex approval processes with highest reliability. You ensure that regulatory requirements are not only met, but anticipated – and thus contribute directly to DENK PHARMA's 'Access to Healing' mission.

How to make your contribution with us: Team leadership Management responsibility: Lead, inspire and develop your team – from work students to experienced Regulatory Affairs Managers – on the basis of our core values, so that each team member knows what to do and achieves top performance together with you. Capacity control: Plane capacities predictively and dynamically adjust the task distribution in the team so that resources are used optimally and regulatory deadlines are reliably maintained. Talent development: Recognize individual strengths in the team and promote them through feedback, coaching and clear development perspectives – and create a culture in which continuous growth is self-evident. Registration planning: Develop a forward-looking submission plan for new product authorisations in the German and European market and ensure its consistent implementation together with your team. Regulatory Monitoring: Keep an overview of the developing regulatory requirements of German authorities such as the BfArM and at European level and derive proactive measures that your team always keep one step ahead. Dossier Quality: Response the technical quality assurance of filing documents according to EU CTD standard in order to precisely meet regulatory requirements and to minimize authorisation risks at an early stage. Interface ManagementCommunication: Design a constructive and reliable cooperation with the BfArM, EMA and other relevant authorities to ensure that approval procedures run efficiently and smoothly. Internal networking: Working in partnership with internal areas such as Sales, Supply Chain, Quality and Pharmacovigilance, so that regulatory processes are seamlessly integrated into the entire company. Partner Management: Select powerful external regulatory partners and service providers carefully and steure them professionally to establish a resilient basis for sustainable growth. Strategy & GrowthMarket Development: Responsibility for regulatory feasibility studies for new products in the German and European market, creating a sound basis for decision-making for strategic growth initiatives. Budget Responsibility: Create and follow the budget plan for your area and, together with your team, realise concrete growth potentials as well as targeted cost reductions – transparent and result-oriented. Process optimization: Identify potential for improvement in existing authorisation processes and actively promote their implementation to continuously increase efficiency and quality.

Education: You have a successfully completed university degree, preferably in pharmacy, natural sciences or medicine, or a completed training from the medical-technical or scientific field. Regulatory experience: You have already gained well-founded experience in Regulatory Affairs – with a demonstrable focus on the German market and cooperation with German regulatory authorities such as the BfArM; Knowledge of the European regulatory environment is also a prerequisite. Leadership experience: Ideally, you bring experience in managing teams or projects and understand how to advance as an inspiring personality and inspire others for common goals. Language skills: You are sure to move to a very good level in German and English – both languages are used in public administration communication and internal and external exchange. Result orientation: A structured, targeted way of working, in which you define goals clearly, concretely and measurablely and consistently promote their implementation, is obvious to you. Own initiative: Not only do you want to grow personally, but you also want to actively initiate valuable changes in the company – and you have the drive to implement them with sustainable success. AI Mindset: You are proving AI-assisted tools – for example for regulatory research, the preparation of government requests or the monitoring of legislative changes – curiously and contributes to how we continuously smarter regulatory affairs at DENK PHARMA.

Work & Life – Flexible working hours and mobile work Connect & Grow – Numerous corporate events such as meadow visit, summer festival, carnival and Christmas celebration, annual team event and regular after-work events on our roof terrace Share & Create – Open exchange and feedback z. by monthly pulse surveys and regular feedback and development talks with your leadership Level up – Focus & Development of your strengths as well as needs-based internal and external workshops for your personal and professional growth Access to healing – Health and fitness cooperation with the EGYM Wellpass, free dietary supplements and snacks (fruit, nuts & ice cream) Buddy Program – Point of contact for all kinds of questions and support during networking and “Get Together Lunch” In addition – 150 € shopping card, exclusive discounts via corporate benefits, a performance-based bonus, company pensions, etc.

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