Biotech Regulatory Affairs Lead: Global Submissions

EPM Scientific; Summit (NJ); Presencial; USD 120 000 - 170 000; Tempo integral

Resumo da oferta

EPM Scientific is recruiting a Senior Regulatory Affairs Specialist in Summit, New Jersey. The candidate will lead regulatory strategy, interact with FDA/other health authorities, and manage global submissions for both development and marketed products.

The role partners with cross-functional teams to ensure lifecycle regulatory compliance, staying current with evolving guidelines and industry trends in a fast-paced biotech environment.

Qualificações

• Bachelor's degree with 7+ years or Master's degree with 5+ years of regulatory affairs experience in pharma/biotech.
• Experience supporting regulatory submissions and health authority interactions.
• Strong knowledge of FDA, ICH, and global regulatory requirements.

Responsabilidades

• Serve as a Regulatory Affairs subject matter expert across the organization.
• Prepare, review, and approve CTDs and other regulatory submissions for compliance and technical accuracy.
• Support U.S. and global regulatory strategies for development and commercial products.
• Coordinate responses to health authority requests and inquiries.
• Monitor regulatory guidance, requirements, and industry trends.
• Author and review Regulatory Affairs SOPs and related documentation.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Conhecimentos

Regulatory affairs

Health authority interactions

FDA knowledge

ICH guidelines

Project management

Cross-functional collaboration

Regulatory submissions

Formação académica

Bachelor's degree

Master's degree

Descrição da oferta de emprego

EPM Scientific is recruiting a Senior Regulatory Affairs Specialist in Summit, New Jersey. The candidate will lead regulatory strategy, interact with FDA/other health authorities, and manage global submissions for both development and marketed products.

The role partners with cross-functional teams to ensure lifecycle regulatory compliance, staying current with evolving guidelines and industry trends in a fast-paced biotech environment.