Remote Regulatory Affairs Director: ANDA & FDA Strategy

Padagis; Michigan; On-site; USD 170,000 - 210,000; Full time

Job summary

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including ANDAs across various dosage forms.

The role requires leading cross-functional teams, guiding development programs, and interfacing with the FDA to ensure compliant filings. The position emphasizes strategic regulatory leadership, risk mitigation, and timely communications with regulatory agencies to support successful market entry

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• Experience: 7-10+ years in Regulatory Affairs.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Strong knowledge of FDA regulations and guidelines.
• Exceptional project management and communication skills.

Responsibilities

• Develop and lead regulatory strategies to support development and submissions (INDs/NDAs/ANDAs).
• Oversee preparation, submission, and management of regulatory documents to FDA.
• Coordinate with R&D, Clinical Affairs, Quality, and Manufacturing for submission packages.
• Serve as primary FDA liaison and coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Mentor junior staff and help build a high-performing regulatory team.
• Support REMS coordination and post-approval regulatory commitments.

Skills

Regulatory strategy

Leadership

Regulatory submissions

Cross-functional collaboration

Project management

Communication

Regulatory affairs knowledge (FDA)

Education

Advanced degree in life sciences/pharmacy

Job description

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for U.S. market products, including ANDAs across various dosage forms.

The role requires leading cross-functional teams, guiding development programs, and interfacing with the FDA to ensure compliant filings. The position emphasizes strategic regulatory leadership, risk mitigation, and timely communications with regulatory agencies to support successful market entry