Regulatory Affairs Director — FDA Submissions & Strategy

Padagis; New Hope (MN); On-site; USD 140,000 - 210,000; Full time

Job summary

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including generics across multiple dosage forms. This remote-eligible role favors candidates in the Minneapolis–St. Paul area.

You will lead cross-functional teams, coordinate FDA interactions, and ensure compliant development and launch activities throughout preclinical, clinical, and manufacturing stages.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7-10+ years regulatory affairs in pharmaceutical/biotech.
• Proven track record leading ANDA, IND, NDA submissions with the FDA.
• Experience in regulatory strategy planning for generic drugs.
• Strong knowledge of FDA regulations for preclinical, clinical, and CMC submissions.
• Excellent project management, prioritization, and communication.

Responsibilities

• Develop and implement regulatory strategies to support development programs.
• Lead preparation, submission, and management of INDs, NDAs, ANDAs and amendments to FDA.
• Coordinate submission timelines and ensure timely filings within project deadlines.
• Collaborate with R&D, Clinical, Quality, and Manufacturing to finalize submission packages.
• Liaise with FDA for Pre-IND, End-of-Phase, Pre-NDA meetings and respond to FDA queries.
• Mentor junior staff and lead regulatory process improvements.

Skills

Regulatory leadership

Regulatory strategy

FDA submissions

Cross-functional collaboration

Communication

Education

Advanced degree in life sciences, pharmacy, or related field

Job description

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including generics across multiple dosage forms. This remote-eligible role favors candidates in the Minneapolis–St. Paul area.

You will lead cross-functional teams, coordinate FDA interactions, and ensure compliant development and launch activities throughout preclinical, clinical, and manufacturing stages.