Remote Associate Director, Regulatory Affairs (FDA/ANDA)

Padagis; Minneapolis (MN); On-site; USD 140,000 - 200,000; Full time

Job summary

Padagis US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and writing for US generic pharmaceutical products. The role oversees IND/NDAs/ANDAs and cross-functional collaboration to ensure FDA compliance and timely approvals.

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

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.
• Strong knowledge of FDA regulations for preclinical, clinical, and CMC submissions.
• Excellent communication and interpersonal skills.

Responsibilities

• Develop regulatory strategies to support development phase according to FDA guidances and trends.
• Provide regulatory leadership during all development phases (preclinical, clinical, manufacturing).
• Assess regulatory risks and mitigate challenges proactively.
• Oversee regulatory submissions and approvals (INDs, NDAs, ANDAs, amendments).
• Plan and execute submission timelines to meet project deadlines.
• Collaborate with R&D, Clinical Affairs, Quality, and Manufacturing to finalize submission packages.
• Serve as primary FDA contact and coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA, etc.).
• Respond to FDA queries promptly to maintain project momentum.
• Ensure regulatory compliance in launch, advertising, and post-marketing activities.
• Support REMS coordination and post-approval commitments.

Skills

Regulatory leadership

FDA submissions

Cross-functional collaboration

Regulatory strategy development

Project management

Education

Advanced degree in life sciences/pharmacy

Job description

Padagis US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and writing for US generic pharmaceutical products. The role oversees IND/NDAs/ANDAs and cross-functional collaboration to ensure FDA compliance and timely approvals.

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