Senior Associate Director, Regulatory Excellence Team Lead (Remote)

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 Associate Director, Regulatory Excellence Team Lead directs, leads, and manages the Regulatory Affairs (RA) capability leads. The incumbent thinks beyond the RA function and constantly identifies areas for improvement in a patient-centric, forward-looking way to enable current and future processes which result in excellence of RA. This will be combined with efficient processes to allow for compliant operations in RA. The incumbent is a critical driver of RA excellence within BI. This role is managing the capability leads for RA and will be an important contributor to drive the regulatory excellence and operations function. 

The SR AD, Regulatory Excellence Team Lead is responsible for the development of capability roadmaps, standards and capability strategy following the guardrails of the ever-changing regulatory environment and the global department strategy which is provided by the GRA Leadership Team. This role ensures capability governance, alignment of standards, deliveries and cross-capability exchange within GRA and beyond. The incumbent provides leadership and expertise to cross-functional teams working around Regulatory Affairs and beyond (e.g., HPQ, PSPV, CD&O, xTA, IT...).

Duties & Responsibilities

• Leads and manages the Capability Leads in GRA. 
• Coaches/directs/oversees team members to design, develop, and implement projects, on time and in budget.  Performance of established processes is monitored and subject to process improvement as necessary.
• Develops overall vision for the GRA Excellence and the GRA Capability strategy and creates a roadmap and prioritization, that anticipates the demands of pipeline and the changing Regulatory Environment while keeping patients, regulatory needs, priorities and resources at front of mind. 
• Oversees and seeks for alignment across capabilities in GRA and beyond.
• Strongly considers external trends in health authorities and the competitive environment.
• Steers as necessary strategic external partnerships/engagements that are part of a global process environment and system implementation for Regulatory Operations / Regulatory Affairs.
• Requires connectivity and understanding of the internal and the external environment, alignment with other Capability areas in GRA, end users and key stakeholders demands and needs, cross-functional and vendor systems and collaboration models. Focus is across Capabilities and standalone Projects/Programs.
• Ultimately accountable for alignment of GRA capability roadmaps, the capability framework/standards, definition of over-all process-landscape, implementation of quality parameters in GRA-processes and for continuous process improvement for GRA capabilities.
• Oversees overall framework with regards to Processes and Capabilities for GRA.
• Ensures cross-capability impact of process-changes, projects and implementation of IT solutions are taken care of.

Ensures capability development and deliverables for GRA which includes:

• Stakeholder feedback and commitment.
• AS-IS process analyses.
• Process governance and documentation / Process architecture.
• Designed IT solutions aligned with the process goals and business case.
• Process monitoring plans which appropriately depict process performance.
• Process measures/metrics and technical feasibility.
• Architectural integrity during each life cycle development stage.
• Participation, contribution to the inspections/audits for the defined capability area.
• Oversight of process NCs/CAPAs, roadmaps, identifies problems, gaps and opportunities for process improvement.

Contributes to the development of personnel, with a focus on GRA-Capability Leads. This is done through:

• Coaching/directing (as appropriate based on individual and situation) of Capability team members.
• Optimizing capability development flow.
• Awareness and introduction of latest functional and regulatory developments in the pharma industry.
• Supporting consistency and compliance.
• Establishing area-relevant standards.
• Encouraging innovation.