Remote Regulatory Affairs Director – ANDA Strategy Lead

Regulatory Jobs; Fort Snelling Unorganized Territory (MN); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Padagis US LLC is seeking a Director/Associate Director of Regulatory Affairs to lead regulatory strategies and submissions for US-marketed pharmaceutical products, with a focus on ANDA submissions across various dosage forms. The role emphasizes cross-functional collaboration to ensure regulatory compliance from development through launch.

The position offers remote work eligibility for US residents with a preference for candidates in the Minneapolis–Saint Paul area, and requires experience

Qualifications

• Advanced degree in life sciences or related field.
• 7–10+ years of regulatory affairs experience in pharma/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Experience with regulatory strategy for generics and combination products.
• Excellent communication and project management skills.

Responsibilities

• Develop and execute regulatory strategies to support development and submission plans.
• Oversee preparation and submission of regulatory documents (INDs, NDAs, ANDAs) and amendments.
• Coordinate with Regulatory Affairs leadership and cross-functional teams (R&D, QC/QA, Manufacturing).
• Serve as primary FDA liaison and manage meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Ensure compliance across launch, advertising, and post-marketing activities.

Skills

Regulatory leadership

FDA regulations

Strategic planning

Cross-functional collaboration

Education

Life sciences advanced degree

Job description

Padagis US LLC is seeking a Director/Associate Director of Regulatory Affairs to lead regulatory strategies and submissions for US-marketed pharmaceutical products, with a focus on ANDA submissions across various dosage forms. The role emphasizes cross-functional collaboration to ensure regulatory compliance from development through launch.

The position offers remote work eligibility for US residents with a preference for candidates in the Minneapolis–Saint Paul area, and requires experience