Regulatory Affairs Project Manager

A hard-working and driven professional, strongly focused in improving the quality of regulatory submission publishing activities and ensuring client’s expectations are delivered on time and with high quality. Monitors and shares industry changes by actively assisting and participating in Health Authorities webinars and workshops, sharing knowledge and direction with the publishing team afterwards by updating publishing processes, manual templates, and specific submission requirements. Currently working as Project Leader providing leadership and oversight of the whole project, including lifecycle maintenance and additional services, budget, resources, timelines, process improvement, contract.

Key Responsibilities

Project Leadership and Oversight:

• Provide comprehensive leadership for regulatory submission projects, including lifecycle maintenance and additional services.
• Manage project budgets, resources, and timelines.
• Implement process improvements and oversee contract management.
• Focus on Biotech and Enterprise accounts.

Regulatory Submission Excellence:

• Monitor and share industry changes by participating in Health Authorities webinars and workshops.
• Update publishing processes, manual templates, and specific submission requirements.
• Ensure high-quality regulatory submission publishing activities.

Client Management:

• Conduct project status analysis to assess current and future client needs.
• Lead kick-off meetings and follow up with sponsors to ensure resolution of agreed items.
• Prepare and deliver project reports.
• Plan upcoming submissions and provide regulatory/eCTD consulting.

Global Resource Management:

• Plan and manage global resources for regulatory submission projects.
• Coordinate global Safety Report (SAE/SUSARs) and Cross Safety Reporting for multiple clinical studies across regions.

Business Development:

• Network within the industry and inform management of potential new business leads.
• Interact with sponsors and team leadership to ensure projects proceed on time and within budget.

Qualifications:

• Proven experience in regulatory submission project leadership.
• Strong knowledge of regulatory submission processes and eCTD requirements.
• Excellent project management skills, including budget and resource management.
• Outstanding communication and leadership abilities.
• Ability to work effectively with global teams and clients.
• Proactive approach to process improvement and industry knowledge sharing.
• Experience with safety reporting coordination is a plus.

Studies & knowledge:

• BA in Pharma, Bio pharmacy and related studies
• Excellent English skills (oral, comprehensive and written).

The ideal candidate will be detail-oriented, able to manage multiple projects simultaneously, and committed to delivering high-quality results in a fast-paced environment. If you are passionate about regulatory submissions and have a track record of successful project leadership, we encourage you to apply for this exciting opportunity.