Job Details

Senior Associate Director, Regulatory Excellence Team Lead

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 Senior Associate Director, 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...).

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.

Requirements:

• Master's degree (e.g., MBA, MSc) or comparable professional education, preferably in medicine/science, paramedical science, computer science, business management or related experience.
• Five to seven (5-7) years' 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.
• Demonstrates the ability to obtain maximum results from meetings in which interests conflict both in terms of content and maintaining good relations.
• Solution-oriented and collaborative ways of working.
• Visionary: Ability to step back from one's 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.
• Develops (& discovers) individuals & builds effective teams.
• Customer orientation: Ability to engage with customers, building strong customer relationships and delivering customer-centric solutions actively and truly.
• Stakeholder management: Ability to effectively build and manage relationships with many different (internal & external) stakeholders, engaging with them in a planned and meaningful way in pursuit of our strategic objectives, and feeding intelligence back across BI to deliver maximum.
• (Agile) Project Management: Ability to initiating, plan, executing, controlling and closing projects including reporting on results and/or lessons learned.
• Effective Communication & Influencing Skills: Ability to have a positive impact on others, to persuade or convince them to gain their support. Excellent public speaking and presentation to large audiences, fluent in written and spoken English.
• Solid Medical/Scientific understanding, incl. general understanding of Pharma industry, rules and regulations.
• Financial acumen: Ability to interpret and apply understanding of key financial indicators to make better business decisions.
• Effective cross-functional collaboration: Ability to develop and maintain relations, alliances and coalitions within and outside the organization and to use them to obtain information, support and cooperation.
• Curiosity, innovative thinking: Ability and a strong desire to know or learn something, inquisitiveness, interest, curiousness.
• Digital savviness: Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
• Integrity and Compliance Mindset: Adherence to the standards, values and rules of conduct associated with one's position and the culture in which one operates.
• Pro-active result driven behavior: The ability to take direct action to attain or exceed objectives.
• Outcome orientation: is driven by outcomes and results.
• Data-driven insights generation: Ability to take decisions based on data analysis and interpretation.
• Efficiency: Discipline & accountability.
• Demonstrated competencies in Agility, Accountability and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, purpose orientation, smart risk-taking.

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. 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.