Regulatory Affairs Project Manager
Argentina, Remote Additional Locations Sao Paulo,Brazil Job ID R0000029705 Category Regulatory / Consulting Date Posted 11/29/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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.
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