R&D Global Regulatory Strategy Director

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma‑derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a R&D Global Regulatory Strategy Director like you.

The Director, R&D Global Regulatory Strategy serves as the strategic regulatory leader for assigned development biologic products on global project teams from preclinical stage to approval. This role is accountable for developing, owning, and implementing comprehensive worldwide regulatory strategies that support R&D objectives for new product development, and new indication expansions as well as for clinical aspects of Life Cycle Management Projects.

Being the Global Regulatory Lead on global project teams, ensures that regulatory considerations are integrated into key decisions, development plans, and business strategies.

The Director, R&D Global Regulatory Strategy drives interactions with global health authorities to expedite approvals and interprets complex regulatory guidelines to ensure compliance and strategic advantage. Proactively assesses regulatory risks, opportunities, and pathways, anticipating challenges, and proposing innovative solutions to accelerate development.

The role also provides leadership and coordination to the Regulatory Teams, offering mentorship, direction, and driving collaboration as well as consistent execution of regulatory milestones and deliverables. Ensures alignment with senior stakeholders, and. fosters regulatory excellence and alignment between regulatory strategy, project goals, and broader organizational objectives.

• As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and initiatives affecting new products or new indication development. Responsible for clinical aspects of LCM initiatives.
• Leads the regulatory team assigned to the respective project to ensure alignment and integration of all aspects of development and seamless execution of strategy and submissions.
• Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
• Serves as a resource to other departments inside and outside of R&D on regulatory‑related product development issues.
• Guides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members.
• Advises Senior Management on regulatory aspects of product development and/or lifecycle management.
• Constantly monitors the evolving regulatory landscape of regulations, identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making.
• Serves as Grifols regulatory liaison in collaborative projects with other companies as assigned.
• Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
• Manages department resources and budget to meet R&D goals.
• Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

To perform this job successfully, an individual must be able to perform each essential duty…