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Team Lead Regulatory Excellence(m/w/x)

Boehringer Ingelheim GmbH
Ingelheim am Rhein

You will lead the development and governance of capability strategies in Regulatory Affairs, ensuring alignment with regulatory requirements while promoting cross-functional collaboration and strategic partnerships.

Anforderungen

  • •Master's degree in medicine or science preferred
  • •Experience in Regulatory Affairs ideally
  • •Ability to manage conflicting interests
  • •Value for collaborative ways of working
  • •Ability to see broader context
  • •Strong customer relationship building skills
  • •Solid Medical/Scientific understanding required
  • •Financial acumen for business decisions
  • •Develop and maintain external alliances
  • •Adhere to standards and values mandatory
  • •Pro-active result driven behavior expected
  • •Driven by outcomes and results required
  • •Ability to generate data-driven insights

Deine Aufgaben

  • •Develop capability roadmaps and standards.
  • •Ensure governance and alignment of capabilities.
  • •Provide leadership for cross-functional teams.
  • •Create vision for GRA Excellence strategy.
  • •Anticipate regulatory demands in the pipeline.
  • •Keep patient needs and regulatory priorities central.
  • •Consider external trends in health authorities.
  • •Steer strategic external partnerships and engagements.
  • •Align capability roadmaps and process landscape.
  • •Implement quality parameters in GRA processes.
  • •Support development of GRA-Capability Leads.

Original Beschreibung

# Team Lead Regulatory Excellence ## The Position At Boehringer Ingelheim, we are dedicated to improving the health and quality of life of patients worldwide. We are currently seeking a dynamic and forward-thinking individual to join our team as a Team Lead Regulatory Excellence. This is a unique opportunity to lead and manage the Regulatory Affairs (RA) capability leads and drive excellence within our RA function. In this role, you will be a critical driver of RA excellence within Boehringer Ingelheim. You will think beyond the RA function, constantly identifying areas for improvement in a patient-centric, forward-looking way. Your work will enable current and future processes that result in the excellence of RA, combined with efficient processes for compliant operations. If you are a strategic thinker with a passion for excellence and a deep understanding of the pharmaceutical industry, we would love to hear from you. Join us in our mission to create and sustain high-quality healthcare solutions that make a difference in people's lives. This position can be filled in different countries: ## Tasks & responsibilities * As the Team Lead Regulatory Excellence, you will be responsible for the development of capability roadmaps, standards, and capability strategy. You will follow the guardrails of the ever-changing regulatory environment and the global department strategy provided by the GRA Leadership Team. * Your role will also involve ensuring capability governance, aligning standards, deliveries, and cross-capability exchange within GRA and beyond. You will provide leadership and expertise to cross-functional teams working in areas such as Regulatory Affairs, HPQ, PSPV, CD&O, xTA, IT, and more. * Additionally, you will develop the overall vision for the GRA Excellence and the GRA Capability strategy, creating a roadmap and prioritization that anticipates the demands of the pipeline and the changing Regulatory Environment. * You will keep patients, regulatory needs, priorities, and resources at the forefront of all decisions and actions and oversee and seek alignment across capabilities in GRA and beyond. * You will strongly consider external trends in health authorities and the competitive environment strongly. * Finally, you will steer strategic external partnerships/engagements that are part of a global process environment and system implementation for Regulatory Operations / Regulatory Affairs as necessary. * Be ultimately accountable for the alignment of GRA capability roadmaps, the capability framework/standards, and the definition of the overall process landscape. * Implement quality parameters in GRA processes and continuously improve GRA capabilities. * Contribute to the development of personnel, with a focus on GRA-Capability Leads. ## Requirements * A Master’s degree (e.g. MBA, MSc) or comparable professional education is required, preferably in medicine / science, paramedical science, computer science, business management or related experiences. * The candidate should have experience in Regulatory Affairs, business/process consulting, project management, external relationship management, business architecture management, and/or implementation of systems in the GxP area, ideally in a global setting. * The ability to obtain maximum results from meetings in which interests conflict both in terms of content and maintaining good relations is a must. * We value solution-oriented and collaborative ways of working. * The ideal candidate can step back from their daily routine, explore ideas for the future, regard the facts from a distance and see them in a broader context or in the longer term. * Building strong customer relationships and delivering customer-centric solutions is key, as is the ability to effectively build and manage relationships with many different (internal & external) stakeholders. * A solid Medical/Scientific understanding, including a general understanding of the Pharma industry, rules and regulations, is necessary. * The candidate should possess financial acumen, specifically the ability to interpret and apply understanding of key financial indicators to make better business decisions. * Developing and maintaining relations, alliances and coalitions within and outside the organization is a requirement. * The candidate should adhere to the standards, values and rules of conduct associated with their position and the culture in which they operate. * We are looking for a candidate with a pro-active result driven behavior, specifically the ability to take direct action in order to attain or exceed objectives. * The candidate should be driven by outcomes and results. * The ability to generate data-driven insights and take decisions based on data analysis and interpretation is a must.
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