Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant (GRO RPSM) open to Spain, Portugal and UK location

Overview

As Regulatory Project Manager, you will drive regulatory project management for a single Sponsor, coordinating global regulatory affairs and submissions. You’ll partner with cross-functional teams to advance the sponsor’s portfolio, manage timelines and risks, and support regulatory strategies across regions. This role offers exposure to global submissions, diverse regions, and a clear path to shaping regulatory outcomes within a fast-paced life sciences environment. You will help deliver compliant, timely submissions that enable product progress and patient access.

Responsibilities

• Provide regulatory project management support for the Sponsor portfolio
• Coordinate global regulatory submissions and lifecycle management across multiple regions
• Manage timelines, risks, issues, and cross-functional communications
• Facilitate submission planning and alignment with Regulatory Affairs and QA
• Support regulatory strategy and documentation to ensure timely approvals
• Lead or participate in cross-functional project teams to drive milestones
• Maintain knowledge of regulatory guidelines (FDA, EMA, ICH) and leverage best practices
• Utilize project management tools to track progress and performance

Key requirements

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred
• 8+ years in regulatory affairs or project management in pharma/biotech
• 7–10 years cross-functional project management experience
• Experience with global regulatory submissions (multiple regions) from submission to approval
• Experience with small molecules and biologics; familiarity with Asia Pacific, Europe, UK, US, and other regions
• Strong organizational, communication, and problem-solving abilities; continuous improvement mindset
• PMP or RAC certification preferred
• Working knowledge of project management systems; proficient in MS Office; experience with Smartsheet, ThinkCell, Office Timeline, MS Project; Lucidchart/Visio a bonus
• Regulatory Information Management Systems experience (e.g., Veeva Vault RIM)

• strong communication
• problem-solving
• multi-tasking and prioritization
• Regulatory project management
• Global regulatory submissions
• MS Office Suite

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