Director, US Product Group Regulatory Affairs

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.

*This role requires you to work on a hybrid schedule meaning 2-3 days per week at our Ridgefield, CT location*

For assigned development projects and US marketed products, the Director, US Product Group Regulatory Affairs will provide expert US regulatory leadership to the global and US cross-functional teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. As a member of the Regulatory Excellence Team, the position holder will provide US regulatory input into the Global Regulatory strategy for assigned projects and represent US RA on US cross-functional teams.

The Director, US Product Group Regulatory Affairs will act as primary company liaison with the US Food and Drug Administration. This role will develop comprehensive, well-thought through US regulatory strategies to navigate the intricate US regulatory landscape, ensuring compliance with relevant guidelines and regulations. The incumbent will assess regulatory risks, options, and opportunities, anticipate potential challenges and propose innovative solutions to accelerate the development and approval process, leveraging the full breadth of US regulatory pathways. This role will collaborate closely with US stakeholders to align US regulatory strategies with the overall business objectives.  

The Director, US Product Group Regulatory Affairs will maintain current expertise on developments in the assigned therapeutic area from a global regulatory, legislative, scientific, pharmaceutical, pharmacovigilance, market access and commercial perspective. This role will engage in US regulatory policy development and foster external stakeholder interactions. The incumbent will provide expertise on regulatory standards and departmental policies.

The Director, US Product Group Regulatory Affairs will proactively participate in US/global cross-functional meetings and discussions, ensuring that US regulatory considerations are incorporated timely and comprehensively at key inflection points and in the decision-making process. This role is an advocate for US regulatory excellence and drive alignment between regulatory strategies and overall project and business goals.

Duties & Responsibilities

Regulatory Professionalism:

• Seamlessly interacts and collaborates effectively at all levels organization (local and global) within RA and across functions.
• Advocates to effectively, efficiently and proactively drives project goals, presenting well-grounded, strategically thought-through options and arguments to independently achieve success regulatory outcomes.
• Maintains the highest stands of professionalism, ethics, and regulatory compliance.

Regulatory Excellence Team (RET)and Intra-RA Project Responsibilities:

• Recognized expert in contributing a broad range of US operational and strategic perspectives to Regulatory Excellence Team (RET).  
• Actively collaborates with RET to align regulatory strategies with product development plans.
• Proactively provides regulatory input and options during all stages of product development to ensure potential challenges and requirements are addressed from the start.
• Jointly problem-solves to address issues and find innovative solutions that align with business objectives while meeting regulatory standards. Shares successful use cases, where applicable.
• Provides regular updates on US regulatory milestones and their impact on the overall project timelines.
• Presents or supports review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate. 
• Independently ensures US RA contributions to all local and global project related documentation (e.g., Global RA Strategy, Risk Assessments, Labeling) are clear, complete and accurate, taking on leadership of the content/information, as appropriate.

Other Regulatory Contributions:

• Provides US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products,