Remote Associate Director, Regulatory Affairs – ANDA Focus

Padagis; Lunenburg (MA); Remote; USD 170,000 - 230,000; Full time

Job summary

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies, submissions and writing for US generic products (ANDA/IND/NDA). The role is remote eligible for US residents, with preference for candidates in the Minneapolis–St. Paul area.

You will lead cross‑functional teams, liaise with the FDA, plan submission timelines, and guide development to secure timely FDA approvals while ensuring post‑marketing compliance and REMS coordination.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7-10+ years of Regulatory Affairs experience in pharmaceutical/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.
• Experience planning regulatory strategy for generics.
• Strong knowledge of FDA regulations for preclinical, clinical, and CMC.
• Excellent project management and ability to handle multiple priorities.
• Excellent communication and collaboration skills.

Responsibilities

• Develop and implement regulatory strategies to support development per FDA guidances.
• Lead submissions and manage documentation for INDs, NDAs, ANDAs.
• Coordinate with cross-functional teams to finalize submission packages.
• Serve as liaison with FDA; manage meetings and respond to requests.
• Ensure regulatory compliance in launch, advertising, post-marketing activities.
• Support REMS coordination and post-approval commitments.

Skills

Regulatory strategy

FDA regulations

IND/NDAs/ANDAs

Leadership

Project management

Cross-functional collaboration

Education

Advanced degree in life sciences

Job description

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies, submissions and writing for US generic products (ANDA/IND/NDA). The role is remote eligible for US residents, with preference for candidates in the Minneapolis–St. Paul area.

You will lead cross‑functional teams, liaise with the FDA, plan submission timelines, and guide development to secure timely FDA approvals while ensuring post‑marketing compliance and REMS coordination.