Remote Regulatory Affairs Lead: FDA Submissions & Strategy

Padagis; Waunakee (WI); On-site; USD 180,000 - 240,000; Full time

Job summary

Padagis US LLC seeks a Director/Associate Director of Regulatory Affairs to lead regulatory strategy, submissions, and writing for US products, primarily ANDAs for generics. You will guide development and coordinate with R&D, Quality, and Manufacturing to ensure timely FDA filings.

This remote role is open to candidates nationwide with preference for the Minneapolis–St. Paul area; you will mentor staff and ensure compliant, high-quality submissions.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7-10+ years in Regulatory Affairs in pharma/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Experience in regulatory strategy for generic drugs and combo products.
• Strong knowledge of FDA regs across preclinical, clinical, and CMC.

Responsibilities

• Develop and oversee regulatory strategies for development and submissions.
• Lead preparation, submission, and management of INDs, NDAs, ANDAs and amendments.
• Manage submission timelines and ensure timely filings.
• Serve as primary FDA contact and coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Mentor junior regulatory staff and lead cross-functional teams.

Skills

Regulatory strategy

FDA liaison

IND/NDAs/ANDAs submissions

Cross-functional collaboration

Project management

Regulatory knowledge

Education

Advanced degree in life sciences

Job description

Padagis US LLC seeks a Director/Associate Director of Regulatory Affairs to lead regulatory strategy, submissions, and writing for US products, primarily ANDAs for generics. You will guide development and coordinate with R&D, Quality, and Manufacturing to ensure timely FDA filings.

This remote role is open to candidates nationwide with preference for the Minneapolis–St. Paul area; you will mentor staff and ensure compliant, high-quality submissions.