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Grifols · 1 week ago

Director, R&D Global Regulatory Strategy Lead

North Carolina, United States

Full-time

Hybrid

Director/Executive

$180K/yr - $250K/yr

8+ years exp

Grifols is a global healthcare company that has been working to improve health and well-being since 1909. The Director, R&D Global Regulatory Strategy serves as the strategic regulatory leader for assigned development biologic products, accountable for developing and implementing comprehensive worldwide regulatory strategies that support R&D objectives.

BiotechnologyHealth CareManufacturing

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

Qualification

FDA regulationsGlobal regulatory strategyClinical developmentProject managementNegotiation skillsCritical thinkingProblem solvingOral communicationWritten communicationCross-functional collaboration

Required

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