Global Regulatory Policy & Intelligence Director (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, 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 Global Regulatory Policy & Intelligence Director 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 with Europe and the US. This role will coordinate efforts in a highly collaborative cross-functional environment that addresses global policy & intelligence gathering, analysis of changes in the regulatory environment, coordination of policy positions and advocacy strategies to achieve policy goals, working collaboratively with both internal and external stakeholders to influence the policy environment set by 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.

Duties & Responsibilities

• Coordinates and executes regulatory intelligence and policy strategies and operations to address current and future business needs in partnership with internal global, regional, and country level RA functions.
• Understands draft legislation, regulations, guidelines, and policies at the global level, 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 coordinate 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 Regulatory Intelligence and Policy team, possessing functional and soft skill to drive strategic intelligence and policy goals.
• Serves as a member Global Regulatory Intelligence & Policy team with direct engagement with RA regions for strategic execution of Global RA goals and priorities.

Requirements

• Doctoral Degree (e.g. PhD, MD) and/or Master’s Degree (e.g. German approbation) in pharmacy or life sciences.
• Ten-plus (10+) years of regulatory affairs experience with practical knowledge and expertise in Regulatory intelligence & policy with the EU and/or 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’s with sound knowledge of intelligence tools and methods; preference will be given to candidates with therapeutic area experience (i.e., oncology).
• 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.

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 delivery under tight timelines.
• Conflict management skills.
• Strategic and visionary personality who is focused, creative, courageous, and able to navigate ambiguity and is able to 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.