Regulatory Affairs Fellow: Global Strategy & US Regs

Boehringer Ingelheim; Ridgefield (CT); On-site; USD 72,000 - 88,000; Full time

Job summary

Boehringer Ingelheim seeks a Regulatory Affairs Fellow to develop US regulatory strategy within a global development context. You will interact with Regulatory Affairs and other functions, advocating for US considerations in project work.

Under supervision, you will support US regulatory topics, ensure clear documentation, and provide guidance on FDA submissions and pediatric development requirements. This is an opportunity to grow in a global biopharma setting.

Qualifications

• Pharmacy degree (ACPE-accredited) or Ph.D. in a related field.
• Ability to perform MEDLINE and EMBASE literature searches.
• Strong interpersonal, active listening, and problem-solving skills.
• Self-motivated and proactive, capable of contributing to team deliverables.
• Ability to work independently with guidance from team leads.
• Adaptable to multiple Therapeutic Areas as needed.
• Excellent verbal and written communication skills.
• Experience in a dynamic, high-volume environment.
• Proficient in Outlook, Word, PowerPoint, and Excel.

Responsibilities

• Develop basic regulatory strategy knowledge in one or more therapeutic areas.
• Interact within Regulatory Affairs and across functions as a US regulatory advocate.
• Lead US operational and strategic perspectives within RA subteams.
• Provide US regulatory input to content of draft CCDS and regulatory documents.
• Support global development projects with US regulatory insights and alignment.

Skills

Interpersonal skills

Active listening

Problem solving

Education

Doctor of Pharmacy degree (ACPE-accredited)

Ph.D. degree in related discipline

Tools

Outlook

Word

PowerPoint

Excel

Job description

Boehringer Ingelheim seeks a Regulatory Affairs Fellow to develop US regulatory strategy within a global development context. You will interact with Regulatory Affairs and other functions, advocating for US considerations in project work.

Under supervision, you will support US regulatory topics, ensure clear documentation, and provide guidance on FDA submissions and pediatric development requirements. This is an opportunity to grow in a global biopharma setting.