Senior Regulatory Affairs Lead - FDA Submissions

Padagis; Wyoming (MI); Presencial; USD 180.000 - 230.000; Jornada completa

Descripción de la vacante

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US pharmaceutical products, primarily ANDAs for generics, spanning various dosage forms.

The role requires cross-functional collaboration with R&D, Clinical, Quality, and Manufacturing, with FDA liaison responsibilities and REMS coordination. Remote-work eligible for US residents, preference for Minneapolis–St Paul area.

Formación

• Advanced degree in life sciences, pharmacy, or a related field.
• 7–10+ years of regulatory affairs experience in pharma/biotech.
• Proven track record leading ANDA, IND, NDA submissions with FDA.
• Experience in regulatory strategy planning for generics and combination products.
• Excellent communication and cross-functional collaboration skills.

Responsabilidades

• Develop regulatory strategies to support development per FDA guidelines.
• Oversee preparation, submission, and management of INDs, NDAs, ANDAs and amendments to FDA.
• Serve as primary regulatory liaison with FDA and coordinate meetings (Pre-IND, End-of-Phase, Pre-NDA).
• Collaborate with R&D, Clinical, QA, and Manufacturing to finalize submission packages and ensure launch readiness.
• Assist REMS coordination and post-approval regulatory commitments.

Conocimientos

Regulatory Affairs

FDA Regulations

ANDA/IND/NDA Submissions

Regulatory Strategy

Project Management

Communication

Educación

Advanced degree in life sciences or pharmacy

Descripción del empleo

Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US pharmaceutical products, primarily ANDAs for generics, spanning various dosage forms.

The role requires cross-functional collaboration with R&D, Clinical, Quality, and Manufacturing, with FDA liaison responsibilities and REMS coordination. Remote-work eligible for US residents, preference for Minneapolis–St Paul area.