Remote Senior Manager, Global Regulatory Submissions

enGene; Boston (MA); Hybrid; USD 145,000 - 185,000; Full time

Job summary

A biotechnology company is seeking a highly motivated Senior Manager for Regulatory Affairs Operations. This role involves overseeing regulatory submissions and managing compliance with global standards. Candidates should have a solid understanding of the pharmaceutical industry, at least 5 years of experience in regulatory operations, and strong skills in document management. The position allows for remote work or requires being based in Boston. The salary range is competitive, between $145k and $185k.

Qualifications

• Minimum of 5 years in pharmaceutical Regulatory Operations.
• Experience managing eCTD submissions to health authorities.
• Knowledge of US, EU, and Canada regional requirements.

Responsibilities

• Lead regulatory operations across assigned programs.
• Oversee eCTD vendor for quality submissions.
• Create checklists, user guides, and SOPs.

Skills

Regulatory submission management

Document formatting standards

Strong organizational skills

Knowledge of ICH, FDA, EMA guidelines

Excellent communication

Education

Bachelor's degree or related experience

Tools

eCTD publishing software

SharePoint

Job description

A biotechnology company is seeking a highly motivated Senior Manager for Regulatory Affairs Operations. This role involves overseeing regulatory submissions and managing compliance with global standards. Candidates should have a solid understanding of the pharmaceutical industry, at least 5 years of experience in regulatory operations, and strong skills in document management. The position allows for remote work or requires being based in Boston. The salary range is competitive, between $145k and $185k.