Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

Are you an experienced Regulatory Affairs Project Manager looking for a challenging contract role in Lisbon? Join a leading global clinical research organisation supporting innovative healthcare projects across multiple regions.

Location: Lisbon, Portugal

Duration: 6-month contract

You will provide strategic regulatory leadership and project management support for complex global submissions, working closely with cross-functional teams, clients, and regulatory authorities. You’ll play a key role in ensuring project delivery, quality standards, and compliance with international regulatory guidelines.

Responsibilities:

• Prepare and review regulatory submissions across multiple markets
• Advise internal and external stakeholders on regulatory strategy
• Lead project-specific regulatory activities with global oversight
• Manage project budgeting, forecasting, and scope control
• Collaborate with global teams and external partners
• Ensure compliance with SOPs and regulatory frameworks
• Mentor and support team members

Requirements:

• Degree in a science-related field
• Proven experience in Regulatory Affairs project management
• Strong knowledge of global regulatory requirements and post-approval processes
• Experience with CMC documentation, RIM systems, and electronic submissions
• Leadership experience with the ability to motivate and guide teams