PpWould 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. /p pbWe 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. /b /p pHelp 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 RD Global Regulatory Strategy Director like you. /p h3Mission /h3 pThe Director, RD 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 RD 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. /p pThe Director, RD 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. /p pThe 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. /p h3What your responsibilities will be /h3 ul liAs 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. /li liLeads 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. /li liLeads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business. /li liServes as a resource to other departments inside and outside of RD on regulatory‑related product development issues. /li liGuides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members. /li liAdvises Senior Management on regulatory aspects of product development and/or lifecycle management. /li liConstantly 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. /li liServes as Grifols regulatory liaison in collaborative projects with other companies as assigned. /li liEnsures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. /li liManages department resources and budget to meet RD goals. /li liUtilizes 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. /li /ul h3Who you are /h3 pTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). /p ul liRequires ., Pharm. D.,. or equivalent. /li li8 years’ direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry. /li liFluent English /li liComprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry. /li liDeep experience in clinical development, trial design statistical principles is essential. /li liExcellent oral and written communication skills. /li liStrong critical thinking and problem‑solving skills. /li liExcellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. /li liAbility to work cross‑functionally to effectively implement and oversee RD regulatory programs. /li liAbility to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. /li liAbility to work within a global team framework and multi‑cultural environment. /li /ul h3What we offer /h3 pIt is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. /p pInformation about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply! /p pWe look forward to receiving your application! /p pWe believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. /p /p #J-18808-Ljbffr