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.