Remote Associate Director, Regulatory Affairs ANDA/IND

Padagis; Foley (AL); On-site; USD 170,000 - 210,000; Full time

Job summary

Padagis US LLC seeks a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US-market pharmaceutical products, primarily ANDAs. The role requires leading regulatory efforts across preclinical, clinical, and manufacturing stages and coordinating with internal teams and FDA stakeholders.

The ideal candidate will have 7–10+ years in Regulatory Affairs, with a track record in generic drug regulatory submissions and strong FDA guidance knowledge.

Qualifications

• Advanced degree in life sciences, pharmacy, or a related field (required).
• 7-10+ years regulatory affairs experience in pharmaceutical/biotech industries (required).
• Proven track record leading ANDA, IND, NDA submissions and FDA approvals.

Responsibilities

• Develop and implement regulatory strategies to support development and submissions (INDs/NDAs/ANDAs).
• Lead regulatory submissions, reviews, and approvals in collaboration with R&D, QA, manufacturing, and clinical teams.
• Act as primary FDA liaison and coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Provide mentorship to junior regulatory staff and help build a high-performing team.
• Ensure regulatory compliance across launch, advertising, and post-marketing surveillance.

Skills

Regulatory leadership

Cross-functional collaboration

Project management

Regulatory strategy

FDA liaison

Effective communication

Education

Advanced degree in life sciences or pharmacy

Job description

Padagis US LLC seeks a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US-market pharmaceutical products, primarily ANDAs. The role requires leading regulatory efforts across preclinical, clinical, and manufacturing stages and coordinating with internal teams and FDA stakeholders.

The ideal candidate will have 7–10+ years in Regulatory Affairs, with a track record in generic drug regulatory submissions and strong FDA guidance knowledge.