Senior Manager, Regulatory Operations

Job overview

The Senior Manager, Regulatory Operations role is onsite in Cambridge, MA, with a base salary range of $145,000–$175,000 per year. The role supports Parabilis Medicines, a clinical-stage biopharmaceutical company developing medicines for serious diseases. The manager provides operational leadership for global regulatory submissions, regulatory information management, publishing, and regulatory technology. The role helps establish scalable processes and internal publishing capabilities so submissions are high-quality, compliant, and timely.

What you'll do

• Provide operational leadership for global regulatory submissions from planning through archival
• serve as business lead for Regulatory Information Management and Veeva RIM Basics
• partner with stakeholders to implement standardized document lifecycle management
• support transition to an internal regulatory publishing model
• maintain inspection-ready regulatory information for U.S. and global submissions
• partner with the Director of Regulatory Operations to modernize processes through technology and automation. Requires approximately six or more years of Regulatory Operations experience and experience supporting FDA electronic submissions, eCTD publishing, Veeva RIM, global submissions, and regulatory systems.

What we're looking for

Skills & competencies

senior manager

regulatory operations

regulatory submissions

veeva rim

ectd publishing

biopharmaceutical

cambridge ma

parabilis medicines

$145k–$175k/year

fda submissions

regulatory affairs

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual target bonus, equity, and a comprehensive benefits package.

Why this role

The posting lists a $145,000–$175,000 base salary range, annual target bonus, equity, and a comprehensive benefits package. The role requires attendance at in-person meetings.

About the employer

Parabilis Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.