Director, US Regulatory Affairs Pharmaceuticals

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.

The Director, US Regulatory Affairs Pharmaceuticals leads the US Regulatory Affairs (RA) Pre and Post approval organization responsible for the Animal health portfolio of Pharmaceutical, nutraceutical, pesticide & New Innovative products; in close collaboration with Global RA, Global Innovation (GI), Global Supply (GS), Global Quality and Commercial Operations. This role is responsible for licensing and Safety & Efficacy support in the USA and International markets for all new product types and entities licensed via FDA-CVM & EPA and as well as Life Cycle Management of existing products in accordance with company priorities and governance.

The Director, US Regulatory Affairs Pharmaceuticals is a key interface with US Regulatory Authorities such as the FDA & EPA and drives regulatory framework and BI position on key regulatory topics. The incumbent represents BI externally on a multinational basis.

Duties & Responsibilities

• Leads and is accountable for external representation: Key communication interface and influencer with Regulatory Authorities.
• Responsible for proactively seeking contact with Authorities directly in the USA or through local RA as appropriate and positioning BI as a trusted and innovative partner (key account management).
• Ensures a balanced relationship with the authorities.
• Is a highly effective communicator with external authorities, agencies and internal stakeholders and senior leadership.
• Provides clarity and interpret relevant legislation and translate into actionable areas to increase the predictability and probability of success for our projects and activities.
• Works globally and closely in cooperation and collaboration with other RA leadership positions in the best interests of the global team ensuring agility, accountability and intrapreneurship across the function.
• Leads regulatory support for Authority site inspections and provides leadership and advice to Clinical, GS and Quality.
• Works globally and closely in cooperation and collaboration with other RA leadership positions in best interests of the global team to maintain agility, accountability and intrapreneurship across the function.
• Leads leaders and technical experts and mentors regulatory teams and colleagues globally, providing innovative solutions to challenges of the organization and our portfolio.
• Responsible for hiring, retaining and developing Regulatory team members and identifying talent for future success.
• Seeks ways to measure and increase team engagement and productivity.
• Ensures functional excellence of members and promotes an entrepreneurial and proactive spirit.
• Demonstrates and promotes Our Behaviors with key stakeholders.
• Responsible for managing cost center and budget for function and associated activities
• Ensures integrity of our regulatory compliance with the respective authorities.
• Provides service to all our operations in the respective scope of their responsibilities: Global Innovation, Global Supply, Strategic business units, Commercial operations including local RA teams in international locations.

Is an internal service provider who is responsible (and accountable) for leading a team which:

• Proactively and in an entrepreneurial manner provides guidance to GI project teams for optimal registration strategies in the USA, balancing compliance and risk factors with speed to market.
• Prepares, submits and achieves marketing authorizations in a timely manner, achieving a competitive label.
• Professionally and proactively addresses needs of internal stakeholders with urgency
• Is responsible for increasing productivity that maximizes product lifecycle opportunities in line with business strategy.
• Is responsible for maintaining up to date technical regulatory data and information for use in dossier preparation for BI submissions to Authorities.
• Develops and implements strategies for quick resolutions of regulatory issues arising during the post approval and re-registration cycle.
• Responsible for identifying regulatory trends and driving strategies to manage and address in the interests of BI.

Requirements

• Bachelor’s degree required in Life Sciences such as Biology, Toxicology, Pharmacy or equivalent with fifteen (15) years of experience; Advanced degree e.g. PhD, Veterinary medicine or Medicine strongly preferred.
• Fluent in English.
• Expertise in Regulatory affairs is required with extensive authority interactions and a strong track record of successful influencing.
• Proven leader with demonstrated ability to build and lead high performing teams.
• Strong team player.
• Demonstrated ability to successfully collaborate and lead people in a complex global organization.
• Excellent communicator and negotiator with ability to form successful working relationships at all levels across disciplines and geographies.
• Exhibits Our Behaviors.
• Enthusiastic mentor, coach and developer of people.
• Self-motivated decision maker, well organized, works to deadlines and with a high degree of initiative and persistence.
• Experience building an organization and leading change management.
• Willingness to travel up to 20%.

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.

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