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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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Director US Regulatory Intelligence and Policy will be a strong subject matter expert in regulatory processes, laws, and regulations, with a comprehensive understanding of how regulatory policy is shaped and developed within the US and globally. This role will coordinate efforts in a highly collaborative cross-functional environment that addresses US policy & intelligence gathering, analysis of changes in the regulatory environment, coordination of policy positions and advocacy strategies to achieve policy goals and working collaboratively with both internal and external stakeholders to influence the policy environment set by FDA and global Health Agencies. This individual will work closely with RA colleagues to coordinate policies around the BI portfolio-assessing the impact of regulatory policy on products and goals. This individual will supervise US Regulatory Intelligence and Policy Fellows and other staff, as assigned.

Duties & Responsibilities

• Coordinates and executes US regulatory intelligence and policy strategies and operations to address current and future business needs in partnership with internal US, global, and regional RA functions.

• Understands draft legislation, regulations, guidelines, and policies in the US, and supports interactions and communications with trade associations and health authorities on regulatory policy matters relevant to organizational positions.

• Effectively supports Boehringer Ingelheim positions and serve as a representative internally and externally on key policy topics to appropriately coordinate engagements within the regulatory environment as well as engage with medical societies and key industry trade associations.

• Provides insights and coordinates for global "one voice" positions on critical regulatory issues and trends to contribute to a broader policy platform.

• Coordinates the deployment of regulatory Intelligence resources and tools as well as access to them and provides focused regulatory insights to the RA organization and other stakeholders.

• Provides strategic expertise as part of the broad Regulatory Intelligence and Policy community, possessing functional and soft skill to drive strategic intelligence and policy goals.

• Serves as a member of the US Regulatory Affairs leadership team with direct engagement and partnership with other US RA leaders for strategic execution of US RA goals and priorities.

• Manages US Regulatory Intelligence and Policy Fellows and other colleagues, as assigned.

Requirements

• Masters and/or Bachelor’s Degree in pharmacy or life sciences.

• Ten-plus (10+) years of regulatory affairs experience with practical knowledge and expertise in Regulatory intelligence & policy in the US.

• Proven capability in acting as a credible, influential, and respected spokesperson able to convey complex messages, trends & insights.

• Deep understanding of the regulatory environment and latest regulations and guidance with sound knowledge of intelligence tools and methods.

• Strong relationship management and interpersonal skills with superb written and oral and communication skills.

• Proven success at stakeholder engagement across organizational levels and boundaries.

• Ability to thrive in a cross-functional team environment with a global mindset.

• Excellent command of English (written and spoken).

Leadership experience:

• Proven experience with international and cross functional projects; Management experience is a plus.

Professional skills:

• Unbiased international view and inter-cultural competence.

• Open minded, motivating personality with drive and initiative.

• Integrative personality with good interpersonal skills.

• Willingness and ability to create and share knowledge.

• Critical thinker with ability to organize workload, to work well under pressure, define priorities and deliver under tight timelines.

• Conflict management skills.

• Strategic and visionary personality who is focused, creative, courageous, and able to navigate ambiguity and can balance between short-term priorities and long-term vision.

• Willingness and ability to apply scientific knowledge and have sound scientific discussions.

• Ability and willingness to learn continuously, adapt to a changing environment and improve efficiency.

• Skilled in relevant IT applications (Microsoft Office applications as well as regulatory databases and other relevant IT applications) and willingness to learn relevant IT applications and to make use of the benefits of relevant IT applications.

• Excellent project management skills.

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.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

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.