Remote Associate Director, Regulatory Affairs – US Generics

Regulatory Jobs; United States; Remote; USD 150,000 - 230,000; Full time

Job summary

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and writing for U.S. products, with emphasis on ANDAs for generics.

You will partner across R&D, QA, Clinical, and Manufacturing to ensure FDA alignment and timely filings. This role guides products through development, secures FDA approvals, and supports market entry while coordinating with FDA meetings and post-approval commitments.

Qualifications

• Advanced degree in life sciences, pharmacy, or a related field.
• 7–10+ years in Regulatory Affairs within pharma/biotech.
• Proven track record of ANDA, IND, NDA submissions with FDA.

Responsibilities

• Develop regulatory strategies to support product development in line with FDA guidances.
• Lead regulatory submissions, deadlines, and interface with FDA for ANDAs and other filings.
• Mentor junior staff and coordinate cross-functional teams across R&D, QA, and Manufacturing.
• Communicate regulatory plans and risk management to stakeholders.

Skills

Regulatory leadership

FDA submissions (IND/ANDA/NDA)

Regulatory strategy

Cross-functional collaboration

Mentorship/training

Education

Advanced degree in life sciences or pharmacy

Job description

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and writing for U.S. products, with emphasis on ANDAs for generics.

You will partner across R&D, QA, Clinical, and Manufacturing to ensure FDA alignment and timely filings. This role guides products through development, secures FDA approvals, and supports market entry while coordinating with FDA meetings and post-approval commitments.