Global Regulatory Project Lead – Sponsor Portfolio

Syneos Health, Inc.; Barcelona; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant (GRO RPSM) in Barcelona, open to Spain, Portugal, and UK locations. You will lead regulatory project management for a Sponsor portfolio and support Global Regulatory Affairs.

The role requires extensive experience in regulatory submissions, cross-functional collaboration, and a track record of delivering in a global environment. Join a team delivering therapies to patients worldwide.

Formación

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.

Responsabilidades

• Provide regulatory project management support to a single Sponsor and the Global Regulatory Affairs function.
• Coordinate and manage multi-regional regulatory submissions across FDA, EMA, ICH guidelines.
• Lead cross-functional teams to ensure on-time delivery of regulatory milestones.
• Manage multiple submissions simultaneously across regions and product types.

Conocimientos

Cross-functional project management

Global regulatory submissions

Regulatory strategy

FDA/EMA/ICH guidelines

Pharmaceutical development experience

Small molecule & biologics experience

Regulatory risk & issues management

Timeline & critical path management

Educación

Bachelor’s degree in life sciences or regulatory affairs

Herramientas

Microsoft Office Suite

Smartsheet

ThinkCell

Office Timeline

MS Project

Lucidchart

Visio

Veeva Vault RIM

Descripción del empleo

Syneos Health, Inc. is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant (GRO RPSM) in Barcelona, open to Spain, Portugal, and UK locations. You will lead regulatory project management for a Sponsor portfolio and support Global Regulatory Affairs.

The role requires extensive experience in regulatory submissions, cross-functional collaboration, and a track record of delivering in a global environment. Join a team delivering therapies to patients worldwide.