Regulatory Affairs Director — FDA Submissions & Strategy

Padagis; Round Lake (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

Padagis is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US products, including ANDAs for generics. You will lead cross-functional teams, coordinate with the FDA, and guide regulatory activities from development through approval. Remote-friendly with preference for Minneapolis-St.

Paul area. The role requires an advanced degree in life sciences or pharmacy and 7–10+ years of Regulatory Affairs experience, with a proven record

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7–10+ years of Regulatory Affairs experience in pharma/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Experience in regulatory strategy planning for generics.
• Strong knowledge of FDA regulations and guidelines.

Responsibilities

• Develop and implement regulatory strategies to support development per FDA guidance.
• Oversee regulatory submissions (INDs, NDAs, ANDAs) and amendments to FDA.
• Coordinate submission timelines and liaise with FDA for meetings.
• Mentor junior regulatory staff and lead the regulatory team.

Skills

Regulatory Strategy

FDA Regulations

Project Management

Communication

Education

Advanced degree in life sciences/pharmacy

Job description

Padagis is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US products, including ANDAs for generics. You will lead cross-functional teams, coordinate with the FDA, and guide regulatory activities from development through approval. Remote-friendly with preference for Minneapolis-St.

Paul area. The role requires an advanced degree in life sciences or pharmacy and 7–10+ years of Regulatory Affairs experience, with a proven record