Global Regulatory Submissions Lead

Merida Biosciences; Cambridge (MA); On-site; USD 200,000 - 240,000; Full time

Job summary

Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs.

This hands-on role drives document readiness, eCTD publishing, cross-functional coordination with regulatory affairs, and strategic execution to ensure timely, compliant submissions while enabling efficient regulatory operations.

Qualifications

• Bachelor's degree in Life Sciences or related discipline; advanced degree preferred.
• 7+ years of regulatory affairs/operations experience in pharma/biotech.
• Knowledge of global regulatory frameworks (FDA/EMA/ICH).
• Experience with RIMS/EDMS and eCTD publishing; Veeva Vault Regulatory preferred.

Responsibilities

• Plan, coordinate, and execute global regulatory submissions (INDs, CTAs, BLAs, NDAs, MAAs).
• Manage submission timelines and deliverables across cross-functional teams.
• Coordinate document readiness, publishing, QC, and eCTD processes.

Skills

Regulatory expertise

Project management

Cross-functional collaboration

Attention to detail

Education

Bachelor's in Life Sciences

MS or MBA (preferred)

PMP (preferred)

Tools

RIMS

EDMS

Veeva Vault Regulatory

eCTD publishing tools

MS Office

Smartsheet

MS Project

Job description

Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs.

This hands-on role drives document readiness, eCTD publishing, cross-functional coordination with regulatory affairs, and strategic execution to ensure timely, compliant submissions while enabling efficient regulatory operations.