Remote Regulatory Affairs Director – FDA Submissions

Padagis; Navarre (FL); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies and submissions for U.S. market products, including generics. The role requires guiding INDs, NDAs, ANDAs and post-approval commitments while coordinating with R&D, QA, and Manufacturing teams.

The position emphasizes risk assessment, regulatory leadership across development stages, and responsibility as FDA liaison. Remote work is eligible for U.S.

Formación

• 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 the FDA.
• Experience in regulatory strategy for generic drugs and combination products.
• Strong knowledge of FDA regulations for preclinical, clinical, and CMC submissions.

Responsabilidades

• Develop and implement regulatory strategies for development phases per FDA guidance and trends.
• Oversee preparation, submission, and management of INDs, NDAs, ANDAs and amendments to the FDA.
• Coordinate submission timelines and ensure timely filings within project deadlines.
• Serve as primary FDA contact, coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA) and respond to FDA inquiries.
• Collaborate with R&D, Clinical, QA, and Manufacturing to finalize submission packages.
• Support REMS and post-approval regulatory commitments; assist launch activities for compliance.

Conocimientos

Regulatory strategy

Leadership

FDA liaison

Cross-functional collaboration

Educación

Advanced degree in life sciences/pharmacy

Descripción del empleo

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies and submissions for U.S. market products, including generics. The role requires guiding INDs, NDAs, ANDAs and post-approval commitments while coordinating with R&D, QA, and Manufacturing teams.

The position emphasizes risk assessment, regulatory leadership across development stages, and responsibility as FDA liaison. Remote work is eligible for U.S.