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As an Associate Director Regulatory in the Legal & Regulatory Compliance department at Grifols, you will play a critical leadership role in shaping and executing regulatory strategy for our biotechnology portfolio. Working within ABC Healthcare, a leading provider in the healthcare industry dedicated to improving patient outcomes through innovation, you will partner closely with legal, clinical, quality, and commercial colleagues to ensure that our products meet global regulatory requirements while supporting timely development and patient access. In this highly visible position, you will lead the planning, preparation, and submission of regulatory dossiers and associated documentation for investigational and marketed products, including INDs, BLAs, NDAs, CTAs, and post-approval changes.
You will interpret and apply relevant FDA, EMA, ICH, and other international regulations and guidelines, advising senior leadership on regulatory pathways, risks, and opportunities. Drawing on your deep understanding of GxP requirements and biotechnology development, you will guide cross-functional teams to design compliant strategies that align with business objectives and protect patient safety. You will collaborate closely with the Legal & Regulatory Compliance function to ensure that labeling, advertising, and promotional materials are accurate, substantiated, and consistent with approved product information.
You will contribute to the development and maintenance of internal policies, SOPs, and governance frameworks that support robust regulatory compliance across the organization. Acting as a primary point of contact with health authorities, you will coordinate meeting requests, briefing packages, and responses to regulatory queries, representing the company in a professional and solution-oriented manner. You will support and, where appropriate, lead regulatory aspects of inspections and audits, including readiness activities, on-site support, and follow-up on corrective and preventive actions.
In alignment with ABC Healthcare’s culture of teamwork, compassion, and continuous learning, you will mentor and develop junior regulatory professionals, fostering a collaborative and inclusive environment where diverse perspectives are valued. You will help drive a culture of continuous improvement by monitoring emerging regulatory trends, conducting regulatory intelligence, and communicating their implications for our products, processes, and policies. This role offers the opportunity to innovate within patient care by enabling the development and commercialization of cutting-edge biotechnology solutions, while working with a dedicated, multidisciplinary team.
The Associate Director
Regulatory will be expected to manage multiple complex projects simultaneously, prioritize effectively in a fast-paced environment, and communicate clearly with stakeholders at all levels. Success in this position will require strategic thinking, strong analytical and problem-solving skills, and the ability to translate regulatory requirements into practical, business-aligned solutions that ultimately support better outcomes for patients.
