Senior Global Regulatory Project Lead

Syneos Health; Lisboa; On-site; EUR 75,000 - 110,000; Full time

Job summary

Syneos Health is seeking a Senior Regulatory Project Manager to lead regulatory initiatives for a single Sponsor across international regions. The role focuses on end-to-end project management of regulatory submissions and lifecycle activities, collaborating with Global Regulatory Affairs and cross-functional teams.

The ideal candidate brings 8+ years in regulatory affairs or PM within pharma/biotech, with hands-on experience in multiple regions and strong delivery performance.

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 activities experience.
• Global regulatory submissions; FDA, EMA, ICH familiarity.
• Managed multiple Marketing Applications and/or LCM submissions across regions.
• Pharma development and regulatory global submissions; small molecules and biologics.
• Strong organizational, communication, and problem-solving skills.
• Experience with regional filing: Asia Pacific, Europe, UK, Switzerland, etc.
• PM fundamentals: meeting facilitation, timelines, critical path, risk/issue mgmt.

Responsibilities

• Provide regulatory project management support to a single Sponsor portfolio.
• Support Global Regulatory Affairs within the Regulatory PM function.

Skills

Project management

Regulatory affairs

Cross-functional collaboration

Timeline management

Risk & issues management

Education

Bachelor's degree in life sciences/pharmacy/regulatory affairs

Tools

Smartsheet

ThinkCell

Office Timeline

MS Project

Lucidchart

Visio

Veeva Vault RIM

Job description

Syneos Health is seeking a Senior Regulatory Project Manager to lead regulatory initiatives for a single Sponsor across international regions. The role focuses on end-to-end project management of regulatory submissions and lifecycle activities, collaborating with Global Regulatory Affairs and cross-functional teams.

The ideal candidate brings 8+ years in regulatory affairs or PM within pharma/biotech, with hands-on experience in multiple regions and strong delivery performance.