Senior Global Regulatory Project Manager

Syneos Health; España; Presencial; GBP 90.000 - 120.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant (GRO RPSM) open to Spain, Portugal and UK. You will provide regulatory project management support to a growing sponsor portfolio and work within the Regulatory Project Management Function.

Responsibilities include overseeing global regulatory submissions, coordinating cross-functional teams, and ensuring timelines and compliance across regions including Europe/UK.

Formación

• Bachelor's degree in life sciences, pharmacy, regulatory affairs or related field is required.
• 8+ years in regulatory affairs or project management within pharma/biotech.
• Experience leading cross-functional PM activities and global submissions.
• Proven track record managing multiple Marketing Applications and/or NVS submissions across regions.

Responsabilidades

• Provide regulatory project management support to a single Sponsor and Global Regulatory Affairs.
• Coordinate cross-functional teams to ensure timely global submissions and lifecycle management.
• Maintain adherence to FDA, EMA, ICH guidelines and regional filing requirements.

Conocimientos

Regulatory Affairs

GxP Compliance

Project Management

Cross-functional Leadership

Global Submissions

FDA EMA ICH Knowledge

Multi-Region Filings

Educación

Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field

Herramientas

Smartsheet

ThinkCell

Office Timeline

MS Project

Lucidchart

Visio

Veeva Vault RIM

Descripción del empleo

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant (GRO RPSM) open to Spain, Portugal and UK. You will provide regulatory project management support to a growing sponsor portfolio and work within the Regulatory Project Management Function.

Responsibilities include overseeing global regulatory submissions, coordinating cross-functional teams, and ensuring timelines and compliance across regions including Europe/UK.