Global Regulatory Affairs Lead for Drug Development

Regulatory Jobs; Germantown (MD); Presencial; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

Precigen, based in Germantown, Maryland, seeks a Senior Manager/Manager of Regulatory Affairs to drive global regulatory strategies for early and late-stage drug development. The role collaborates with QA, CMC, preclinical and clinical teams to ensure regulatory commitments are met.

The position requires strong leadership, regulatory knowledge, and experience with IND/BLA submissions; travel may be required to interact with authorities and project teams.

Formación

• Bachelor's degree in life science or related field; advanced degree preferred.
• Five (5) years of direct regulatory affairs experience in biotech or pharmaceutical environments.
• Experience in compilation of Regulatory submissions using eCTD (electronic common technical document) is preferred.

Responsabilidades

• Manage day-to-day Regulatory Affairs activities for investigational and commercial products; act as liaison with FDA and global authorities.
• Support regulatory strategies to align with development and marketing objectives; collaborate with senior regulatory management.
• Identify and assess regulatory risks; implement mitigation strategies across global programs.
• Develop professional relationships with FDA and other authorities to promote positive company image.
• Coordinate regulatory workflow, support and track timelines for area of responsibility.
• Assist with writing/editing of Module 2 Summary sections for IND/BLA submissions.
• Monitor FDA and international guidance and provide training on applicable requirements to scientific staff.

Conocimientos

Leadership

Planning

Organization

Execution

Regulatory knowledge

Communication

Confidentiality

Problem solving

MS Office

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

Precigen, based in Germantown, Maryland, seeks a Senior Manager/Manager of Regulatory Affairs to drive global regulatory strategies for early and late-stage drug development. The role collaborates with QA, CMC, preclinical and clinical teams to ensure regulatory commitments are met.

The position requires strong leadership, regulatory knowledge, and experience with IND/BLA submissions; travel may be required to interact with authorities and project teams.