Senior Regulatory Project Manager — Sponsor-Dedicated

Syneos Health; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Manager to lead regulatory project management for a single sponsor. The role supports Global Regulatory Affairs and oversees multiple submissions across regions, leveraging PM fundamentals and global guidelines.

The position requires extensive experience in regulatory affairs and a track record of managing Marketing Applications and lifecycle management for small molecules and biologics.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field (advanced degree preferred).
• 8+ years of regulatory affairs or project management experience in pharma/biotech.
• 7–10 years of cross-functional PM experience.
• Expertise in global regulatory submissions; familiarity with FDA, EMA, ICH guidelines.

Responsibilities

• Provide regulatory project management support to a single Sponsor within Regulatory PM Function.
• Collaborate with Global Regulatory Affairs to drive submissions and lifecycle management.
• Manage timelines, risks, and issues across multiple regions and submissions.

Skills

Regulatory PM

Cross-functional PM

FDA/EMA/ICH knowledge

PM fundamentals

MS Office

Education

Bachelor’s in life sciences/Regulatory affairs

Tools

Smartsheet

ThinkCell

Office Timeline

MS Project

LucidChart/Visio

Job description

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Manager to lead regulatory project management for a single sponsor. The role supports Global Regulatory Affairs and oversees multiple submissions across regions, leveraging PM fundamentals and global guidelines.

The position requires extensive experience in regulatory affairs and a track record of managing Marketing Applications and lifecycle management for small molecules and biologics.