Ridgefield, CT, 06879, USA
21 hours ago
Sr. GRA Capability Lead
**Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior GRA Capability Lead plays a critical role in shaping the strategic direction and operational excellence of Global Regulatory Affairs (GRA). By driving innovation, harmonizing and standardizing processes, and ensuring regulatory capabilities are future-ready, the role directly supports compliance, efficiency, and transformation across the organization. It bridges business needs with digital and process solutions, ensuring alignment with evolving regulatory demands, supporting process automation and leveraging opportunities of state-of-the-art technology. This role is essential for maintaining a high-performing, compliant, and forward-looking regulatory function. **Duties & Responsibilities** + Shapes and owns a Capability Area through development, implementation, and maintenance of the Strategic Capability Area Roadmap for GRA Capabilities by analyzing trends and proactive identification of opportunities for continuous improvement. + Supports the GRA Strategy by anticipating the demands of the pipeline and the changing Regulatory Environment, while keeping both regulatory excellence and compliance at front of mind. + Generates oversight and transparency on the status of the Capability and related ongoing activities and projects. + Implements and leads Non-Asset Project Portfolio Management for GRA to provide transparency and assess, prioritize and initiate, steer or participate in business process improvement projects in alignment with GRA Objectives, contributing to the GRA Values and to Strategic Goals. + Steers and ensures oversight on demand management and vendor engagement for Capability topics. + Responsible for identification and the strategic leadership of innovative solutions, shaping RA in alignment with GRA Objectives and Medicine Goals. + Responsible to generate a framework of continuous improvement and innovation for the Capability Area. + Coaches other capability Leads and ensures Capability Leads are aligned within a Capability Area. + Initiates and steers strategic internal and external networks and partnerships. This requires deep connectivity and understanding of internal and external environment, alignment with other Capability Areas within and outside GRA, with corporate and local end users, key stakeholders’ demands and needs, as well as with the RIN network. + Responsible for the governing of Value Streams and aligning of GRA- and cross-functional processes to contribute to the GRA Process Landscape and the overall Medicine Business Architecture Framework. + Actively seeks for opportunities to continuously improve and streamline and simplify GRA processes and their interfaces to stake holding functions. + Initiates and leads capability projects to design, develop, and implement quality results, on time and per budget. + Supports Business Process Enablement by contributing to change management and training activities. Serves as- or guide and coach Global Process Owners, Product Owners, Data Governance-, Business SMEs to identify improvement opportunities, enhance efficiencies, define interfaces, and ensure processes, product/technology, and data governance meet operational needs. This includes: + Evaluating processes for stability, cost, inefficiencies, and identifying improvement opportunities. + Modeling lean and robust processes, considering benefits, value, cost, and implementation. + Developing knowledge documentation and creating process monitoring strategies with valid metrics and addressing non-compliance issues. + Identifying and leading of Change Management Strategies for Organizational Improvement Measures. **Requirements** + Bachelor’s degree or comparable professional education in medicine / science, pharmaceutical industry, computer science, business management or related degree required. + Minimum five (5) years of experience in Regulatory Affairs, Clinical Development/Operations, business/process consulting, project management, Pharmacist (Apotheker), external relationship management, business architecture management, and/or implementation of systems in the GCP area, ideally in a global setting. + Strategic & Visionary Thinking: Ability to see the bigger picture, think long-term, and drive innovation. + Deep Regulatory Expertise: Profound understanding of regulatory frameworks, BI internal processes, and the pharmaceutical industry. + Structured and data-driven approach to optimize and govern global regulatory processes, ensuring alignment with compliance standards and operational excellence. + Leadership & Team Development: Builds strong teams, fosters talent, and leads with integrity and purpose. + Stakeholder & Customer Engagement: Strong relationship-building skills with internal/external stakeholders and a customer-centric mindset. + Project & Change Management: Proficient in (Agile) project execution, transformation initiatives, and delivering measurable outcomes. + Communication & Influence: Excellent communicator with strong influencing and presentation skills in English. + Digital & Data Savviness: Leverages digital tools, interprets data for insights, and drives data-informed decisions. + Financial & Business Acumen: Understands financial indicators to support strategic decisions. + Core Behaviors: Demonstrates agility, accountability, intrapreneurship, curiosity, and a proactive, results-driven mindset. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Compensation** This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards) All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Confirmar seu email: Enviar Email