Director, R&D Global Regulatory Strategy Lead

GRIFOLS, S.A.•Clayton, NC

51d•$180,000 - $250,000•Hybrid

About The Position

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.

Requirements

Requires Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
Comprehensive knowledge and understanding of FDA and global regulatory requirements for regulatory pathways and strategies for development projects in the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs. Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

Responsibilities

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