Remote Associate Director, Regulatory Affairs (ANDA/NDA)

Padagis; Hendersonville (TN); On-site; USD 180,000 - 240,000; Full time

Job summary

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to lead regulatory strategy and submissions for U.S. generic products, including ANDAs, INDs and NDAs, coordinating cross-functional teams and FDA communications.

The role focuses on ensuring regulatory compliance, timely filings, and risk mitigation across development stages, with remote eligibility for U.S. residents.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7-10+ years in Regulatory Affairs within pharma/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Experience in regulatory strategy for generics and combination products.
• Strong knowledge of FDA regulations for preclinical, clinical, and CMC submissions.

Responsibilities

• Develop and implement regulatory strategies to support development per FDA guidance.
• Oversee preparation, submission, and management of regulatory documentation (INDs, NDAs, ANDAs).
• Coordinate submission timelines and cross-functional teams for package finalization.
• Serve as primary FDA liaison and facilitate meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Ensure regulatory compliance in launch activities, advertising, and post-marketing surveillance.

Skills

Regulatory strategy

ANDA/IND/NDA submissions

FDA regulations knowledge

Project management

Communication skills

Education

Advanced degree in life sciences / pharmacy

Job description

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to lead regulatory strategy and submissions for U.S. generic products, including ANDAs, INDs and NDAs, coordinating cross-functional teams and FDA communications.

The role focuses on ensuring regulatory compliance, timely filings, and risk mitigation across development stages, with remote eligibility for U.S. residents.