(Archived) Executive Director, US Regulatory Affairs CREA (CNS, Retinopathies & Emerging Areas) Product Group

Description

The Executive Director of the US Regulatory Affairs CREA Product Group serves on the US Regulatory Leadership Team responsible for supporting the management of the US RA organization in collaboration with other functional RA leaders (Promo/Adv, CMC RA, RA Operations, Labeling/Labeling Operations, other Product Group therapeutic areas). This position is responsible for CREA Product Group resource and headcount management, project assignments, product group personnel recruitment, development and performance management and retention. Responsible for multi-year planning and adherence to US RA budget objectives in compliance with Med I (local) and Med II (global) budget requirements. This position also serves on the global RA Leadership Team responsible for active participation in the global Regulatory Expert Group (REG) that provides guidance for all global regulatory strategies for BI development programs. This position is responsible for leadership and collaboration with cross-functional US Integrated Brand Teams for assigned Tas to ensure that the regulatory strategy for the US/FDA is integrated into the overall clinical development plan(s). For assigned projects, this role will supervise regulatory interactions with FDA following appropriate internal processes and collaborating, as appropriate, with relevant internal business partners as well as directly with BIPI and/or global management, whether participating as an individual contributor to assigned programs or as a supervisor for assigned team members. This position is responsible for supervision of all FDA interactions (meetings, communications, documents) related to assigned TAs. Responsible for high quality US submissions (NDA, BLA, supplemental applications) to ensure successful FDA outcomes. This position is responsible for active participation in Regulatory policy topics as well as developing and maintaining relationships with outside organizations/associations to enhance BI reputation and participation in key Industry consortium, working groups, and leadership committees. This role requires participation in FDA led or co-led symposia on topics critical to BI business objectives. When needed, this position will also serve in some capacity as the Global Regulatory Lead (GRL) or as the US Local Regulatory Lead (LRL) for one or more BI investigational product/development program(s) with the responsibilities outlined for the roles and responsibilities for GRL and LRL. 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.

Requirements

• Bachelor´s Degree in science or biopharmaceuticals. Advanced degree preferred.
• Minimum 8-10 years´ experience in the pharmaceutical industry that includes experience in Regulatory Affairs.
• Demonstrated strong leadership and communications skills.
• Ability to lead and develop regulatory professionals assigned.
• Demonstrated ability to develop and implement regulatory development strategies.
• Demonstrated successful track record of health authority (especially FDA) interactions to achieve US and/or international drug registrations.
• Demonstrated successful leadership experience, with demonstrated ability to collaborate in multi-functional, multi-national teams.
• Demonstrated expert knowledge of regulatory requirements and evolving regulatory landscape with the ability to interpret relevance for complex and innovative development projects and marketed product activities. Demonstrated history of applying innovative thinking to regulatory issues.
• Demonstrated ability to effectively prioritize and manage challenging situations.
• Demonstrated ability to coach and mentor regulatory professionals.
• Demonstrated ability to establish strong working relationships internally, cross-functionally, and externally.
• Ability to professionally represent BI on key external leadership working groups and committees.
• Extensive regulatory experience and comprehensive knowledge of FDA regulations and policies.
• Experience in developing and providing in-depth guidance to ensure competitive drug development strategies for investigational and marketed products.
• Operational knowledge of global HA regulations (e.g., EMA) is a development goal in this position if not already a core competency.

Compensation

This position offers a base salary typically between $200,000 and $347,000.  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.