Director, Global Regulatory Submissions & Strategy

pihealth.ai; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Pi Health is seeking an experienced Director/Senior Director of Regulatory Affairs & Submissions Management to lead global submission strategies and ensure high-quality eCTD submissions across the US, UK, EU, and other regions. You will directly oversee INDs, CTAs, CTNs, and HREC submissions while hands-on supporting complex filings in a fast-paced, client-focused environment.

The role combines strategic oversight with practical execution, requiring a track record of IND submissions to the US

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum 5 years in regulatory affairs/submissions management in pharma/biotech/CRO.
• Proven track record submitting INDs to US FDA and CTAs in UK/EU.
• Experience with IRAS and EU CTIS submissions.
• Strong knowledge of ICH/FDA/EU regulations and HRA/MHRA requirements.

Responsibilities

• Direct and oversee submission strategy and content for studies and programs.
• Lead preparation and submission of INDs to US FDA, including amendments and annual reports.
• Lead UK IRAS submissions and EU CTIS CTIS submissions; manage modifications.
• Oversee publishing/validation of eCTD submissions to FDA ESG and regional portals.
• Coordinate regulatory meetings, prepare briefing docs, and track logs.
• Mentor Regulatory Affairs staff and ensure quality/compliance across regions.

Skills

Regulatory strategy

IND submissions

US FDA INDs

CTAs UK/EU

IRAS submissions

CTIS submissions

Cross-functional leadership

Regulatory intelligence

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

eCTD publishing

FDA ESG

Lorenz/docuBridge or similar

IRAS/CTIS portals

Job description

Pi Health is seeking an experienced Director/Senior Director of Regulatory Affairs & Submissions Management to lead global submission strategies and ensure high-quality eCTD submissions across the US, UK, EU, and other regions. You will directly oversee INDs, CTAs, CTNs, and HREC submissions while hands-on supporting complex filings in a fast-paced, client-focused environment.

The role combines strategic oversight with practical execution, requiring a track record of IND submissions to the US