Director, US Regulatory Affairs - Product Group (Hybrid)

Boehringer Ingelheim GmbH; Ridgefield (CT); Hybrid; USD 230.000 - 346.000; Vollzeit

Benefits dieser Stelle

Restaurant/Wellness perks

Zusammenfassung

Boehringer Ingelheim is seeking a Director of Regulatory Affairs US Product Group for a hybrid role in Ridgefield, CT. You will drive US regulatory strategies, lead IND/NDA/BLA submissions, and collaborate with global teams to align regulatory and business objectives.

The role requires extensive FDA experience, strong leadership, and a strategic, proactive approach. Hybrid work 2–3 days onsite in Ridgefield, with responsibilities spanning regulatory policy, risk assessment, and cross-functional

Qualifikationen

• Must hold a life sciences-related degree with extensive drug development/regulatory affairs experience.
• Ability to lead US regulatory strategy and liaise with FDA and cross-functional teams.
• Proven concept-to-submission oversight and regulatory risk management.

Aufgaben

• Lead development of IND/ NDA/ BLA submission documents for US projects.
• Provide US regulatory input to global strategy and ensure timely approvals.
• Represent Boehringer Ingelheim with external authorities and internal teams.

Kenntnisse

Regulatory leadership

FDA interactions

Cross-functional collaboration

Strategic thinking

Ausbildung

Bachelor’s Degree in life sciences or chemistry

Doctoral/Masters in life sciences preferred

Tools

RIMS

EDMS

eCTD tools

Jobbeschreibung

Boehringer Ingelheim is seeking a Director of Regulatory Affairs US Product Group for a hybrid role in Ridgefield, CT. You will drive US regulatory strategies, lead IND/NDA/BLA submissions, and collaborate with global teams to align regulatory and business objectives.

The role requires extensive FDA experience, strong leadership, and a strategic, proactive approach. Hybrid work 2–3 days onsite in Ridgefield, with responsibilities spanning regulatory policy, risk assessment, and cross-functional