At UCB, we put our heart, dedication, and capabilities into making a difference in the lives of people living with severe diseases. By working together to push boundaries, we combine the best of our talents to drive innovation and deliver meaningful impact for patients. Do you want to be part of this pioneering journey?
To strengthen our team, we are looking for a Head of Regulatory Affairs Brazil.
Key Responsibilities:
Regulatory Strategy & Business Partnership
1. Define and lead the overall Regulatory Affairs strategy for Brazil, ensuring alignment with affiliate objectives, global regulatory frameworks, and long-term portfolio strategy.
2. Act as a strategic advisor to senior leadership, providing regulatory insights to support pipeline planning, asset prioritization, investment decisions, and launch readiness.
3. Anticipate regulatory, policies, and environmental changes, translating regulatory intelligence into proactive risk mitigation and business opportunity strategies.
4. Ensure regulatory considerations are integrated into cross-functional decision-making across the full product lifecycle.
Asset Registration & Lifecycle Management
5. Lead regulatory strategy development and execution for new assets, line extensions, and lifecycle management.
6. Oversee the planning, preparation, submission, and maintenance of regulatory dossiers, ensuring quality, consistency, and submissions on time.
7. Drive effective interactions with health authorities, including scientific advice, pre-submission meetings, responses to questions, and follow-up during review and approval processes.
8. -Ensure continuous product compliance post-launch, including renewals, variations, and management of regulatory issues arising during commercialization.
Compliance, Governance & Risk Management
9. Ensure full compliance with Brazilian regulatory requirements, applicable global standards, internal policies, and quality systems.
10. Establish and continuously improve internal regulatory policies, processes, and procedures in line with evolving regulatory expectations.
11. Provide regulatory governance and oversight for audits, inspections, and authority interactions, acting as a regulatory representative.
12. Lead regulatory risk assessment and mitigation activities, including internal audits, lessons learned, and continuous improvement initiatives.
Stakeholder Management & External Engagement
13. Collaborate closely with cross-functional and Global Regulatory teams to ensure alignment between regulatory strategy and business priorities.
14. Build and maintain strong, credible relationships with health authorities and key external stakeholders.
15. Represent the company in industry associations, regulatory working groups, and external forums, contributing to policy discussions and shaping the regulatory environment.
16. Monitor and communicate regulatory trends and policy developments to internal stakeholders, ensuring organizational readiness and compliance.
People Leadership & Organizational Capability
17. Lead, develop, and retain a high-performing team, fostering a culture of strategic thinking, accountability, collaboration, and regulatory excellence.
18. Ensure continuous capability building to meet current and future regulatory complexities.
Operational Management
19. Manage the Local Regulatory Affairs budget and resources, ensuring efficient allocation aligned with strategic priorities and company policies.
20. Oversee regulatory systems, training frameworks, and operational processes to ensure inspection readiness and operational excellence.
21. Drive continuous improvement in regulatory operations, metrics, and performance outcomes.
Requirements:
22. Bachelor's degree
23. Strong experience in Regulatory Affairs within the Brazilian pharmaceutical environment;
24. Fluent English is required.
25. Experience within the context of an international organization.
UCB and its subsidiaries encourage diversity and inclusion in the workplace and are equal opportunity employers.