Team Lead Regulatory Excellence

The Position

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.

If you have any questions about the job posting or process - please contact our HR Direct Team,
Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com