Director, US Regulatory Affairs — Strategic FDA Leader

Boehringer Ingelheim; Ridgefield (CT); Hybrid; USD 230,000 - 346,000; Full time

Job summary

Boehringer Ingelheim is seeking a Director of US Product Group Regulatory Affairs in Ridgefield, CT. The role leads US regulatory strategy, serves as primary liaison with FDA, and partners with global teams to drive regulatory submissions and lifecycle management for US marketed products.

The position requires a strong regulatory background with at least 10 years in Regulatory Affairs, a Bachelor’s in life sciences or related field, and the ability to work in a hybrid onsite model at our

Qualifications

• Minimum 10 years’ experience in Regulatory Affairs, FDA, or equivalent in regulated pharma industry
• Must be legally authorized to work in the United States without restriction
• Bachelor’s Degree in life sciences, pharmacy, or chemistry; advanced degrees preferred

Responsibilities

• Leads US regulatory strategy and timelines for complex projects
• Interacts with FDA and internal stakeholders to align global and US RA activities
• Prepares submission documents and briefing packages for regulatory milestones
• Provide cross-functional leadership and regulatory input to product development plans

Skills

Regulatory leadership

US FDA regulatory

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s Degree in life sciences/pharmacy/chemistry

Doctoral/Master’s degree preferred

Job description

Boehringer Ingelheim is seeking a Director of US Product Group Regulatory Affairs in Ridgefield, CT. The role leads US regulatory strategy, serves as primary liaison with FDA, and partners with global teams to drive regulatory submissions and lifecycle management for US marketed products.

The position requires a strong regulatory background with at least 10 years in Regulatory Affairs, a Bachelor’s in life sciences or related field, and the ability to work in a hybrid onsite model at our