Senior Regulatory Project Manager (Global Sponsor)

Syneos Health; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Senior Regulatory Project Manager to support a dedicated Sponsor portfolio with global regulatory submissions and cross‑functional collaboration. The role focuses on managing timelines, risks, and multi‑region filings across small molecules and biologics.

The ideal candidate brings extensive regulatory program experience, strong PM skills, and readiness to operate in a fast-paced, global environment.

Formación

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• 7–10 years of participation in cross-functional project management activities.
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
• Must have managed multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission to approval.
• Must have pharmaceutical development and regulatory global submissions experience. Must have prior experience with both small molecule and biologics.
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
• Familiarity with regions for filing submission: Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, Japan, United States.
• Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).

Responsabilidades

• The Regulatory Project Manager will work dedicated to a single Sponsor and provide regulatory project management support to the Sponsor Portfolio.
• This role is part of the Regulatory Project Management Function and will support Global Regulatory Affairs.

Conocimientos

PM fundamentals

Cross-functional PM

Regulatory affairs

Global submissions

Communication skills

Educación

Bachelor’s degree in life sciences/regulatory

Advanced degree preferred

Herramientas

MS Office

Smartsheet

ThinkCell

Office Timeline

MS Project

Lucidchart/Visio

Veeva Vault RIM

Descripción del empleo

Syneos Health is seeking a Senior Regulatory Project Manager to support a dedicated Sponsor portfolio with global regulatory submissions and cross‑functional collaboration. The role focuses on managing timelines, risks, and multi‑region filings across small molecules and biologics.

The ideal candidate brings extensive regulatory program experience, strong PM skills, and readiness to operate in a fast-paced, global environment.