Director, US Regulatory Affairs Pharmaceuticals

Director, US Regulatory Affairs Pharmaceuticals

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 opportunities for all employees to collaborate internationally, offering visibility and the chance to directly contribute to the company's success. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work‑life balance.

The competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for its employees.

The Director, US Regulatory Affairs (RA) Pre‑ and Post‑approval organization leads the Animal health portfolio of pharmaceutical, nutraceutical, pesticide, and 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 for life‑cycle management of existing products in accordance with corporate priorities and governance.

The Director is a key interface with US regulatory authorities such as the FDA and EPA and drives the regulatory framework and business intelligence position on key regulatory topics.

• Lead and be accountable for external representation: key communication interface and influencer with regulatory authorities.
• Proactively seek contact with authorities directly in the USA or through local RA and position the company as a trusted, innovative partner.
• Maintain a balanced, high‑quality relationship with authorities.
• Communicate effectively with external authorities, agencies, internal stakeholders and senior leadership.
• Interpret relevant legislation and translate it into actionable strategies to increase predictability and success.
• Collaborate globally with other RA leaders to ensure agility, accountability and intrapreneurship across the function.
• Lead regulatory support for authority site inspections and advise Clinical, GS and Quality teams.
• Mentor regulatory teams and colleagues globally, providing innovative solutions and driving technical excellence.
• Hire, retain and develop regulatory team members, identifying talent for future success.
• Measure and increase team engagement and productivity.
• Ensure integrity of regulatory compliance with the respective authorities.
• Manage cost center, budget for the function and associated activities.
• Provide services to all operations within scope, including Global Innovation, Global Supply, Strategic business units and Commercial operations.

• Bachelor’s degree in Life Sciences such as Biology, Toxicology, Pharmacy or equivalent with fifteen (15) years of experience; advanced degree (e.g., Ph.D., Veterinary Medicine, Medicine) strongly preferred.
• Fluent in English.
• Expertise in Regulatory Affairs with extensive authority interactions and a strong track record of influencing.
• Proven leader with demonstrated ability to build and lead high‑performing teams.
• Strong team player and excellent communicator and negotiator, able to collaborate across disciplines and geographies.
• Enthusiastic mentor, coach and developer of people.
• Self‑motivated decision maker, well organized, and works to deadlines with high initiative and persistence.
• Experience building an organization and leading change management.
• Willingness to travel up to 20%.

• Must be legally authorized to work in the United States without restriction.
• Must be willing to undertake a drug test and post‑offer physical (if required).
• Must be 18 years of age or older.

With us, you can develop your own path in a company that values diverse strengths and fosters innovation. Your development is our priority, supported by authentic, bold culture and a respectful, friendly environment where everyone is valued and welcomed. We invest heavily in global accessibility to healthcare and provide programs that look after your health and wellbeing. Take the next step in transforming lives for generations—visit