Job Description

Our Policy & Government Affairs team collaborate with government entities and policy organizations at local and national levels. We address legislative and regulatory issues that promote the discovery and development of innovative medicines, vaccines and animal health products while improving and protecting patient access to care.

We are looking for an Associate Director Regulatory Affairs, AI and Hyperautomation (m/f/d) who can join our team as soon as possible. This is a full-time and permanent role.

The Associate Director Regulatory Affairs, AI and Hyperautomation position will be responsible for developing, deploying, and maintaining AI and Power Platform capabilities within the Global Regulatory Affairs and Clinical Safety (GRACS) Organization. The role will encompass business operations, technical development, and organizational management. This role will enable business value using citizen development model techniques to enhance processes that are non-GxP and fall outside the scope of core Regulatory system capabilities. The position requires collaboration with stakeholders across the global landscape and will serve as a liaison between the Business Area and IT organizations to define and apply User Requirements for system build/release activities, ensuring delivery timelines are met.

Your profile:

• Bachelor’s degree in Business, Technology (Information Management, Computer Science, Engineering), Analytics, Scientific or relevant business operations discipline is required
• A minimum of 5 years of experience supporting business operations in life sciences, pharmaceutical or related industry are required
• Advanced expertise in Microsoft Power Platform (Power Apps, Power BI, Power Automate, etc.), Microsoft Copilot, MS, Fabric, Microsoft Dynamics 365, Azure, Dataverse, Microsoft Excel and Microsoft Office Suite strongly preferred
• Ability to leveraging a LLM to solve a business solution and highlight the process for identifying the necessary Gen AI steps to load data, learn from data, and predict or generate output leveraging the AI solutions
• Familiarity with open source HuggingFace models, vector embedding, chunking strategies, PEFT, RAG, python
• Experience with Content Management system (e.g., Veeva Vault) and Workflow systems (e.g., Appian)
• Working knowledge of processes, systems and business environment within Regulatory Affairs and / or pharmaceutical setting
• Excellent communication and presentation skills
• Demonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplines
• Growth mindset
• Detail-oriented and able to manage multiple competing priorities executing project plans with a sense of urgency
• Experience working in a cross-functional and collaborative team environment
• Ability to lead by influence and work effectively in matrix organizational structures
• Broad organizational awareness and knowledge of touch points/interdependencies
• Demonstrated Change Management knowledge/experience
• Excellent project management, problem solving, and communication skills

Preferred experience and skills:

• Familiarity with Business System Requirements
• Robotic Process Automation
• Ability to leverage API calls – experience familiarity with JSON / Postman / APIs / Microservices
• MS SQL experience (relational database table structures, stored procedure creation, JSON parsing / logging)
• Object oriented programming, for cases where it makes sense to call external libraries / functions

What we offer

• Exciting work in a great team, global projects, international environment
• Opportunity to learn and grow professionally within the company globally
• Hybrid working model, flexible role pattern
• Pension and health insurance contributions
• Internal reward system plus referral program
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
• Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card
• Vodafone, Raiffeisen Bank, Foodora, and Mall.cz discount programs
• Up-to-date laptop and iPhone
• Parking in the garage, showers, refreshments, massage chairs, library, music corner
• Competitive salary, incentive pay, and many more

Ready to take up the challenge? Apply now!

Know anybody who might be interested? Refer this job!

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

Current Employees apply HERE

Current Contingent Workers apply HERE

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