Director, US Oncology Regulatory Strategy

BioCT Innovation Commons; Ridgefield, Northern (CT, KY); Hybrid; USD 196,000 - 345,000; Full time

Job summary

Boehringer Ingelheim in Ridgefield, CT is seeking a Director/Senior Associate Director of US Product Group Regulatory Affairs to lead regulatory strategy for US development programs. You will partner with global teams, ensure timely submissions, and navigate FDA interactions to support decision making.

The role is hybrid, requiring 2–3 days onsite weekly at the Ridgefield, CT office, with accountability for regulatory milestones, risk assessment, and strategic insights across product lifecycles.

Qualifications

• Bachelor’s Degree in life sciences, pharmacy, or chemistry with extensive drug development knowledge.
• Minimum of ten (10) years’ experience in Regulatory Affairs, FDA, or equivalent.
• Doctoral Degree (PharmD, PhD) and/or Master’s Degree in life sciences, pharmacy, or chemistry, with drug development experience/knowledge preferred.
• Expertise in multiple therapeutic areas and broad range of regulatory topics.

Responsibilities

• Provide US regulatory leadership in preparation of IND/NDA/BLA submissions.
• Develop comprehensive US regulatory strategies aligning with global development plans.
• Represent US RA in cross-functional teams and external interactions with Health Authorities.

Skills

US regulatory expertise

Regulatory strategy

Cross-functional leadership

Education

Bachelor’s Degree in life sciences/pharmacy/chemistry

Master’s or Doctoral degree in life sciences/pharmacy/chemistry

Job description

Boehringer Ingelheim in Ridgefield, CT is seeking a Director/Senior Associate Director of US Product Group Regulatory Affairs to lead regulatory strategy for US development programs. You will partner with global teams, ensure timely submissions, and navigate FDA interactions to support decision making.

The role is hybrid, requiring 2–3 days onsite weekly at the Ridgefield, CT office, with accountability for regulatory milestones, risk assessment, and strategic insights across product lifecycles.