Senior Global Regulatory Project Manager

Syneos Health; Barcelona; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant open to Spain, Portugal, and UK locations. The role focuses on regulatory project management support for a growing Sponsor Portfolio within Global Regulatory Affairs, collaborating with cross-functional teams in a fast-paced environment.

The ideal candidate will have 8+ years in regulatory affairs or PM in pharma/biotech, hands-on experience with global submissions (FDA/EMA/ICH), and a track record

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
• Experience should include 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 the following 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 role will work dedicated to a single Sponsor and will be responsible for providing regulatory project management support to the growing Sponsor Portfolio.
• This person will be a part of the Regulatory Project Management Function with the Sponsor and will support Global Regulatory Affairs.
• Coordinate cross-functional activities for submissions and lifecycle management.
• Facilitate timelines, risk assessments, and issue resolution across global regions.
• Ensure compliance with regulatory guidelines (FDA, EMA, ICH) and strategic regulatory plans.

Conocimientos

PM fundamentals

MS Office Suite

Smartsheet

ThinkCell

MS Project

Visio

Veeva Vault RIM

Educación

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Herramientas

Veeva Vault RIM

Descripción del empleo

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Senior Regulatory Consultant open to Spain, Portugal, and UK locations. The role focuses on regulatory project management support for a growing Sponsor Portfolio within Global Regulatory Affairs, collaborating with cross-functional teams in a fast-paced environment.

The ideal candidate will have 8+ years in regulatory affairs or PM in pharma/biotech, hands-on experience with global submissions (FDA/EMA/ICH), and a track record