Remote Regulatory Affairs Director — Global Submissions

Belenos Biosciences Inc.; New York (NY); À distance; USD 180 000 - 240 000; Plein temps

Résumé du poste

Belenos Biosciences Inc. is seeking a Director/Associate Director, Regulatory Affairs for a remote role in the United States (EST). This hands-on leadership position focuses on regulatory strategy, submissions, and cross-functional collaboration to advance therapeutic programs.

You will lead IND and BLA submissions, guide regulatory planning, and interact with FDA and other authorities, while mentoring teams and ensuring timely, high-quality deliverables across EU and APAC activities.

Qualifications

• BS degree in a scientific discipline; advanced degree is required.
• 8+ years in Regulatory Affairs within biotech/pharma.
• Hands-on experience leading US IND and BLA submissions.
• Strong knowledge of US regulatory requirements and FDA interactions.
• Global regulatory experience including EU and APAC regions.
• Experience developing regulatory strategies across multiple development stages.
• Experience supervising regulatory vendors and CROs.

Responsabilités

• Develop and execute global regulatory strategies aligned with development goals.
• Lead regulatory submissions (IND, BLA, CTA, MAA) and milestones.
• Coordinate regulatory documentation and ensure high-quality deliverables.
• Lead interactions with FDA and other health authorities; develop meeting packages.
• Provide regulatory input to clinical development plans and labeling strategies.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Connaissances

Regulatory strategy

Regulatory leadership

Cross-functional collaboration

FDA interactions

Formation

Bachelor's degree in a scientific discipline

Advanced degree (PhD, PharmD, MS, or equivalent)

Description du poste

Belenos Biosciences Inc. is seeking a Director/Associate Director, Regulatory Affairs for a remote role in the United States (EST). This hands-on leadership position focuses on regulatory strategy, submissions, and cross-functional collaboration to advance therapeutic programs.

You will lead IND and BLA submissions, guide regulatory planning, and interact with FDA and other authorities, while mentoring teams and ensuring timely, high-quality deliverables across EU and APAC activities.